Methods and systems for preventing bleeding from the left atrial appendage

ABSTRACT

The disclosure presents methods and systems for applying a suction force to a surface of a left atrial appendage (LAA) with a tube attached to an exterior surface of an inflatable balloon. The disclosure also presents methods and systems for inflating a first inflatable balloon within a cavity of a left atrial appendage (LAA). A method may include applying a suction force with at least one tube coupled to the first inflatable balloon to attract the first inflatable balloon to an interior surface of the LAA or to a second inflatable balloon. A method may include puncturing, using a tissue-penetrating tip, a target surface of the LAA.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of prior U.S. patent application Ser. No. 14/981,621, entitled “METHODS AND SYSTEMS FOR PREVENTING BLEEDING FROM THE LEFT ATRIAL APPENDAGE,” filed Dec. 28, 2015, which is a continuation-in-part of prior U.S. patent application Ser. No. 14/941,469, entitled “METHODS AND SYSTEMS FOR ACCESSING A PERICARDIAL SPACE AND PREVENTING STROKES ARISING FROM THE LEFT ATRIAL APPENDAGE,” filed Nov. 13, 2015, which is a continuation of prior U.S. patent application Ser. No. 13/973,949, entitled “METHODS AND SYSTEMS FOR ACCESSING A PERICARDIAL SPACE AND PREVENTING STROKES ARISING FROM THE LEFT ATRIAL APPENDAGE,” filed Aug. 22, 2013, which claims the benefit and priority under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 61/692,171, entitled “METHODS AND SYSTEMS FOR ACCESSING A PERICARDIAL SPACE AND PREVENTING STROKES ARISING FROM THE HEART,” filed on Aug. 22, 2012, the entire contents and disclosures of each of these applications being hereby incorporated by reference herein; this application is also a continuation-in-part of prior U.S. patent application Ser. No. 14/941,457, entitled “APPARATUS AND METHOD FOR TREATING BLEEDING ARISING FROM LEFT ATRIAL APPENDAGE,” filed Nov. 13, 2015, which is a continuation of prior U.S. patent application Ser. No. 13/922,070, entitled “APPARATUS AND METHOD FOR TREATING BLEEDING ARISING FROM LEFT ATRIAL APPENDAGE,” filed Jun. 19, 2013, which claims the benefit and priority of U.S. Provisional Patent Application No. 61/661,350, entitled “NOVEL TECHNOLOGY FOR TREATING HEMORRHAGE FROM LEFT ATRIAL APPENDAGE,” filed on Jun. 19, 2012, the entire contents and disclosures of each of these applications being hereby incorporated by reference herein.

BACKGROUND 1. Field

Aspects of the present disclosure relate to medical devices and medical methods. Specifically, aspects of the present disclosure relate to methods and systems for accessing a pericardial space and preventing strokes arising from a left atrial appendage (“LAA”) by achieving a complete occlusion of the LAA using an epicardial approach without creating a puckering of the LAA ostium.

The LAA is a cylindrical, ear-shaped, and sometimes tortuous and pedunculated muscular pouch projecting from the upper anterior portion of the left atrium of the heart. The LAA is a long, tubular, hooked structure and has a narrow junction with the venous component of the atrium. Thus, the LAA lies within the pericardial space, and is an extension of the left atrium. The pericardial space is also commonly known as the pericardial cavity and thus, both terminologies are used synonymously herein. The LAA functions as a decompression chamber during left ventricular systole and during periods when left atrial pressure is high. The LAA is also commonly known as the left auricular appendix, the auricular, or the left auricle. The left atrium receives oxygenated blood from the lungs by way of the pulmonary veins, and pumps the oxygenated blood into the left ventricle via the mitral valve. The LAA is more distensible than the rest of the left atrium and for a given increase in pressure, expands more than the left atrium. In virtually all patients, the LAA has muscle bundles termed pectinate muscles that are more than 1-mm thick with deep crevices or recesses in-between. In addition, in the majority of hearts, distinct protrusions from the LAA body termed lobes are also present within the LAA. The LAA structure has received increasing attention over the past 15-20 years due to its propensity to be a site of blood clot formation especially in patients with atrial fibrillation (“AF”). AF is the most common cause of strokes arising from the heart.

AF patients have a five-fold increased risk of an embolic stroke resulting primarily from thromboembolic events. There is very strong evidence that strokes which occur in AF are thromboembolic, such as, a blood clot which formed in the heart and then breaks off and travels to the blood vessel in the brain. In non-rheumatic AF patients, the stroke-causing thrombus originates almost exclusively from the LAA. Typically, the thrombus formed in the LAA break away from the LAA and accumulates in other blood vessels, thereby blocking blood flow in these blood vessels, and ultimately leading to an embolic stroke. Cardio-embolic strokes related to AF are large and prone to early recurrence with higher mortality. An antithrombotic or anticoagulant drug is one that suppresses, delays, or nullifies blood coagulation. Treatment with antithrombotic agents, such as warfarin, has been the “cornerstone” of medical therapy for these AF patients, but it can be difficult to maintain dosage within the therapeutic range and administration requires frequent monitoring and dose adjustments. Moreover, anticoagulants are associated with undesirable side effects, many of which are exacerbated with advanced age. As high as 50% of elderly patients are not offered anti-coagulation therapy even though they are at the greatest risk of development of embolic strokes. Therefore, alternative management strategies have been proposed, especially for the elderly, depending on the severity of the condition.

As such, the source of the blood clot must be identified to prevent recurrences and thus provide effective alternative therapy. It has been established that AF-related emboli originate primarily in the LAA. Based on this knowledge, procedures have been developed where the LAA is obliterated or excised and thus excluded from the systemic circulation. The aim is to prevent or inhibit thrombi in the LAA from embolizing into the systemic circulation. These procedures include (a) surgeries where the LAA is stapled with an amputating stapling device or sutured closed and/or excised and (b) endocardial procedures where an occlusive device is placed inside the LAA. Both approaches have been successful and are being tested, but also have very significant limitations.

Using stapling and similar technologies to exclude the LAA is often associated with incomplete closure leaving behind a stump. This stump can often serve as a source of future embolism. Similarly endocardial devices also have their share of problems. First, accurate placement of an endocardial device is highly dependent on the anatomy of the LAA, which is unpredictable because the shape and size of the LAA can vary widely. Other limitations of endocardial devices include the use of fixation barbs which can traumatize the LAA wall and incomplete occlusion due to gaps between the endocardial device and the LAA wall. There is also the possibility that the endocardial device may be by itself thrombogenic and it is constantly in contact with left atrial blood. A clip or a suture that is placed outside the heart does not come into contact with blood in the LAA cavity, and is less impacted by the LAA anatomy. The novel technology presented in aspects of this disclosure allow a puncture from the LAA onto the pericardial space in a controlled setting without the development of hemorrhage into the pericardial space. Following this, a catheter is exteriorized and over this, a closure device is inserted via the pericardial space that then clamps shut the LAA ostium.

Using the same principles described above, of expanding elements deployed within the left atrial appendage, it is also possible to cannulate the left atrial appendage from the pericardial space that has been accessed previously using a surgical approach. In doing so, hemostasis is maintained and thus, the approach can be used to create a cannula that can be inserted into the left atrium.

2. Description of the Related Art

A number of approaches for plugging the LAA with an implantable device delivered via an endovascular approach have been proposed. In particular, occlusion of the LAA is believed to decrease the risk of an embolic stroke in non-valvular AF patients. By occluding the LAA, the thrombus formed in the LAA are unable to migrate to other blood vessels, thereby reducing the risks of thromboembolism and embolic stroke. Hence, the occlusion of the LAA is believed to be an effective stroke prevention strategy in non-valvular AF patients. Indeed, this concept of occluding the LAA as a stroke prevention strategy is being increasingly tested with implantable medical devices that occlude the LAA using an endocardial and epicardial approaches.

An example of an endocardial approach is the WATCHMAN device developed by Atritech Inc. (located in Plymouth, Minn.). The WATCHMAN device is an implantable device designed to occlude the LAA in non-valvular AF patients. The WATCHMAN device is delivered to the LAA via an endovascular approach and is placed distal to the LAA ostium, which upon expansion, occludes the LAA. The occlusion of the LAA prevents the migration of the thrombus formed in the LAA, thereby reducing the risks of thromboembolism and embolic stroke. In the WATCHMAN device's clinical trial, PROTECT-AF, the results showed that in AF patients who were candidates for warfarin therapy, the closure of the LAA using the WATCHMAN device was associated with a reduction in hemorrhagic stroke risk as compared to warfarin therapy. Additionally, these results showed that all-cause stroke and all-cause mortality outcomes were non-inferior to warfarin.

However, the WATCHMAN device's “one size or one shape fits all” approach results in several limitations, such as inadequate circulatory exclusion of the LAA. For example, a major limitation of the WATCHMAN device is the incomplete occlusion of the LAA because it is relatively common for there to be a gap between the WATCHMAN device surface and the LAA wall. These gaps are more likely to enlarge over time and persist, while new gaps also occur during follow up. Gaps are also commonly noted to enlarge over time, and new gaps occur during follow up even if the LAA was completely sealed at implantation. The long, tortuous and pedunculated structure of the LAA can make it difficult to seat the device within the LAA cavity. This can result in the device placed in a suboptimal manner with incomplete occlusion, and an incomplete occlusion is worse than no occlusion. Aspects of the present disclosure provide for more refined systems and methods for achieving a complete occlusion of the LAA.

Another limitation of the WATCHMAN device is the fixation of barbs or wires engaged in the walls of the LAA. As shown in the WATCHMAN device's PROTECT-AF trial, major adverse events include bleeding and pericardial effusion. Pericardial effusion is the abnormal accumulation of fluid in the pericardial cavity, which can negatively affect heart function. Aspects of the present disclosure provide for more refined systems and methods for achieving a complete occlusion of the LAA without the risks associated with tears or bleeding arising from the fixation of barbs or wires engaged in the LAA walls and without implanted hardware that is constantly exposed to blood in the LAA cavity.

More recently, EpiTek Inc. (located in Bloomington, Minn.) and SentreHEART, Inc. (located in Redwood City, Calif.) have each developed implantable devices designed to occlude the LAA. The SentreHEART, Inc.'s device is called the LARIAT. These devices are introduced percutaneously into the pericardial cavity, also known as the pericardial space, and then used to place a suture circumferentially at the ostium of the LAA, typically referred to as LAA ligation. Pericardial access is typically established via a subxiphoid approach with a needle. A wire is placed through the needle into the pericardial cavity. A sheath is then placed in the pericardial space through which a catheter is advanced to the desired location. The procedure of obtaining pericardial access with a needle via a subxiphoid approach can be technically difficult, and associated complications include lacerations of the myocardium, the coronary arteries and veins. Unlike the Epitek device, the LARIAT device also involves placement of a balloon within the LAA. Using magnetic forces, the wire within the pericardial space and the balloon in the LAA are made to come into contact. A pre-tied suture that is placed around the LAA is advanced from the exterior over the wire and balloon and then tightened. Due to the severe technical limitations associated with the procedure, it has not been adopted in a widespread manner. Aspects of the present disclosure provide for an anchoring hemostatic mechanism that makes the procedure of accessing the pericardial space safer and less difficult.

LAA ligation from a circumferentially applied suture or tie also suffers from puckering of the occlusion which can compromise sealing. In addition to causing a puckering and incomplete occlusion of the LAA ostium, a circumferential suture also has the disadvantage of having a potential to cause a tear or laceration of the LAA. It is anticipated that in the elderly hearts (the elderly patients are the primary candidates of this approach), which are known to be delicate, this approach may be associated with an even greater risk of bleeding and tears. In the event of a tear of the LAA in the elderly hearts, there is a high likelihood of this being fatal. This is an emergent situation and there will not be time to transfer the patient to the operating room. Aspects of the present disclosure provide for more refined systems and methods for achieving a complete occlusion of the LAA without creating a puckering effect.

For the foregoing reasons, there is a need for novel technology to achieve a complete occlusion of the LAA without creating a puckering of the LAA ostium. Aspects of the present disclosure address this need by presenting methods and systems for achieving a complete occlusion of the LAA using an epicardial approach without creating a puckering of the LAA ostium.

Additionally, within the last decade, there has been an increasing use of a surgically deployable metallic clip that can be place around the base of the LAA. The most prominent among these is the AtriClip manufactured by AtriCure Inc. (located in Cincinnati, Ohio) described in U.S. Patent Application Nos. 2006/027553 and 2009/051270. The AtriClip is made of two parallel rigid titanium tubes with elastic nitinol springs covered with a knit-braided polyester sheath. Deploying the AtriClip is a surgical procedure that requires the chest in between the ribs to be cut open rather than a puncture and is placed over the LAA under direct visualization. It is not a minimally invasive procedure that is necessarily performed by the surgeon rather than the cardiologist.

Methods and apparatus for accessing a pericardial space and optionally placing an external closure over the LAA are described in U.S. Pat. Nos. 6,423,051; 7,951,069; and U.S. Patent Application No. 2011/276,075 (“the '075 application”).

-   -   Aspects of the present disclosure are distinguished from the         aforementioned references for at least the following reasons. In         particular, the '075 application only discloses a single         occlusion member to occlude the LAA that is then followed by an         intentional perforation of the LAA to obtain access to the         pericardial space. The catheter is then exteriorized and using         the exteriorized catheter as a railing, a suture is delivered to         ligate the LAA. Moreover, the '075 application only discloses an         occlusion member inflated within the LAA, in which this one         inflated balloon is used to occlude the entirety of the LAA         cavity. By contrast, a focus of the current disclosure is to         limit or eliminate blood flow through the neck-like ostium of         the LAA. This is achieved by the expansion of a plurality of         inflatable balloons immediately across the LAA ostium both         within the LAA and in the left atrial cavity. The LAA wall has         thick muscle bundles that are more than 1-mm thick with deep         recesses in-between the bundles, giving it a rough appearance.         Protrusions from the LAA wall termed lobes are also seen in the         majority of the hearts. Due to these recesses and lobes, a         single occlusion member within the LAA cavity is unlikely to         provide an effective hemostatic seal. By contrast, aspects of         the present disclosure provide a plurality of inflatable         balloons to provide an effective hemostatic seal.     -   In aspects of the present disclosure, the main occluding element         is deployed within the cavity of the left atrium, rather than         within the LAA. This main occluding element, such as an         inflatable balloon, has dimensions larger than the LAA ostium         when inflated. Thus, when inflated, this main occluding element         envelops the LAA ostium. This main occluding element's surface         is in contact with the smooth surface of the left atrial cavity         wall and upon full deployment, is able to provide an effective         hemostatic seal.     -   The primary purpose of the expandable elements that are within         the LAA, rather than to achieve a hemostatic seal, is to pull         the left atrium cavity balloon towards the LAA ostium (by         application of electromagnetic or magnetic forces) and to jam it         shut. In an exemplary embodiment, the present disclosure         includes the presence of thin tubes attached to the balloon         surface of the left atrium cavity balloon. These tubes allow for         the application of vacuum or suction forces that will be applied         against the smooth-walled left atrium to allow for a more         effective hemostatic seal.     -   The use of multiple inflatable balloons to create a tight         hemostatic seal for occluding the LAA ostium is not presented in         the prior art. In particular, at least one of the inflatable         balloons occluding the LAA ostium is non-compliant, such that         upon inflation of the non-compliant balloon, the surrounding LAA         walls are expanded to accentuate the constriction that one would         expect at the LAA ostium. The use of these multiple inflatable         balloons distinguishes aspects of the present disclosure from         the prior art's single occlusion element that is placed within         the LAA cavity. Hence, embodiments of the present disclosure         should not result in gaps between the occlusion element's         surface and the LAA walls. Second, the use of electromagnetic or         magnetic coils within the inflatable balloons, wherein upon         inflation of these balloons, the electromagnetic or magnetic         coils also expand within these balloons, is not present in the         prior art. These electromagnetic coils further enhance the         hemostatic seal by way of magnetic or electromagnetic forces         between the inflated balloons occluding the LAA ostium. The use         of the electromagnetic coils ensures that embodiments of the         present disclosure do not result in gaps between the occlusion         element's surface and the LAA walls.     -   Another novel feature of aspects of the present disclosure is         the coating of the inflatable balloons with biocompatible         hydrogels to provide a superior seal. Also novel is the presence         of tubules attached primarily to the left atrial cavity balloon         will allow for the vacuum or suction forces that are applied         from an external source. This will result in the left atrial and         LAA tissues adhering to the balloons more effectively, thus         resulting in a superior seal.     -   Embodiments of the present disclosure including a closure device         comprising a suture looped around two semi-rigid tubes further         distinguishes aspects of the present disclosure from the prior         art. The present disclosure's closure device ensures that there         shall be no puckering effect around the LAA ostium commonly seen         in the prior art, such as with the devices developed by EpiTek         Inc. and SentreHEART, Inc. Additionally, the coating of hydrogel         or silicone to the interior surfaces of the two semi-rigid tubes         is another novel feature, ensuring that there is no puckering         effect. Moreover, an anchoring balloon attached to the         exteriorized catheter used to stabilize the LAA while the         closure device is being deployed to the LAA ostium is yet         another distinguishing novel feature. This anchoring mechanism         ensures that the exteriorized catheter, when pulled externally         is able to have its proximal end within the LAA cavity, after         the hemostatic balloons have been deflated and removed.         Furthermore, aspects of the present disclosure provide for an         injuring step that is not present in the prior art.         Specifically, the injury step is designed to induce to induce a         tissue response that enhances the closure and sealing of the LAA         ostium.     -   Embodiments of the present disclosure can also be used for other         purposes to canulate the pericardial cavity. In case it is         decided to not occlude the LAA ostium at the end of the         procedure, the site of puncture in LAA can be sutured closed         with an absorbable or non-absorbable suture (with or without a         collagen pledget) applied from the exterior.     -   It is also anticipated that embodiments of the present         disclosure can be used to occlude or ligate any tubular         structure (vascular or otherwise) within the body (for example         an aneurysm).     -   Using the same principles described above, of expanding elements         deployed within the left atrial appendage, it is also possible         to cannulate the left atrial appendage from the pericardial         space that has been accessed previously using a surgical         approach. In doing so, and using a device that allows for the         application of “counter-pressure,” hemostasis is maintained and         thus, the approach can be used to create a cannula that can be         inserted into the left atrium.         Underlying Principles of Aspects of the Present Disclosure     -   Unlike the right atrial appendage which has a broad based         pyramidal shape, the cylindrical pedunculated shape of the LAA         and the presence of a narrow waist or constriction at the LAA         ostium allows this structure to be occluded by the placement of         expanding elements within or adjacent to the LAA. The LAA is         also more compliant compared to the left atrial cavity allowing         for balloons to be inflated within the LAA.     -   Occluding the LAA allows for the controlled puncture of the LAA         where access to the pericardium can be obtained from the left         atrial cavity, without any bleeding occurring into the         pericardial space. The catheter that is placed in the         pericardium can now puncture the parietal pericardium and be         exteriorized for example in the subxiphoid region. This can be         used to deliver materials and devices to the pericardial space         in a safe manner.     -   However, inflating a cylindrical balloon solely within the LAA         is unlikely to provide a safe and stable hemostatic occlusive         seal for the following reasons. The first reason is the presence         of pectinate muscles and lobes in the LAA. Nearly all adult LAAs         contain pectinate muscles that are greater than 1-mm in         diameter. As a result of these pectinate muscles, the LAA has a         rough quality unlike the left atrial cavity, which is         smooth-walled. Deep recesses are present in the LAA in-between         these pectinate muscles. The LAA also has the presence of larger         distinct protrusions termed lobes. The presence of these lobes         and recesses makes it difficult for a single balloon inflated         within the LAA to provide an effective seal since the cavity of         the lobes and the recesses would allow for blood through flow         through.     -   In some hearts, a distinct constriction is absent at the ostium         of the LAA. In some atria, the constriction when present at the         LAA ostium is not circumferential. This raises the possibility         that upon inflation of a single balloon within the LAA, this         inflated balloon may fall out of the LAA into the left atrial         cavity.     -   Aspects of the novel disclosure presented in this application         solve the above mentioned problems through the following         innovations illustrated by the hour-glass concept.

The Hour-Glass Concept.

-   -   The Hour-Glass concept presents the importance of multiple         inflatable balloons in controlling the neck of the hour-glass.         One of the key factors affecting the time measured in the         hour-glass is the neck width. The neck of the hour-glass         represents the LAA ostium. The top bulb of the hour-glass         represents the left atrial cavity while the bottom bulb of the         house-glass represents the LAA. This hour-glass concept as it         relates to the LAA was conceived by the named inventor on this         patent application.     -   Aspects of the present disclosure are based on the concept that         preventing the sand or water flowing from the top bulb to the         bottom, which is achieved by occluding or sandwiching the neck         by a combination of inflatable balloons that are deployed across         the constriction and forced towards each other rather by         inflating a single balloon in the bottom bulb only. These         inflatable balloons that are placed immediately across the neck         are approximated towards each other by a combination of pushing         and pulling, as detailed in FIGS. 17-18. A first balloon is         inflated within the LAA adjacent to the LAA ostium and a second         balloon is inflated within the distal portions of the LAA. The         inflated second balloon pushes the inflated first balloon         towards the neck of the hour-glass, which represents the LAA         ostium. The inflated first balloon is also pulled towards the         neck of the hour-glass by manual traction on the inner sheath.     -   A third balloon is inflated within the left atrial cavity         adjacent to the LAA ostium. Electromagnetic coils can also be         present within the first and the third balloon. The         electromagnetic coils in the inflated third balloon also pull         the inflated first balloon towards the neck of the hour-glass by         way of electromagnetic forces. Conversely, the electromagnetic         coils in the inflated first balloon pull the inflated third         balloon towards the neck of the hour-glass by way of         electromagnetic or magnetic forces. Thus, the main function of         the inflated first balloon is to pull the inflated third balloon         towards the LAA ostium by way of electromagnetic forces. The         main function of the inflated second balloon is the push the         inflated first balloon towards the LAA ostium.     -   Aspects of the present disclosure present the accentuation or         exaggeration of the LAA ostium by inflating a non-compliant         balloon within the LAA adjacent to the LAA ostium. The first         inflatable balloon is non-compliant and inflated with higher         pressure. A non-compliant balloon is likely to deform the LAA         walls and by creating expanding the LAA walls, it will         accentuate the neck of the hour-glass and allow for a better         approximation of the inflated balloons against the surfaces.         (Hoit B D, Walsh R: Regional atrial distensibility. American         Journal of Physiology 1992; 262:H1356-H1360). The LAA is more         distensible than the left atrial cavity and hence should readily         deform especially in response to high pressure inflation with a         non-compliant balloon. The inflated non-compliant first balloon         is then forced towards the LAA ostium by a combination of         pushing and pulling.     -   The second balloon is largely compliant and is inflated within         the distal portion of the LAA. Upon inflation, the second         balloon conforms to the LAA anatomy and pushes the inflated         first balloon further towards the LAA ostium, as shown on FIGS.         17-18. Additionally, the inflated second balloon prevents the         inflated first balloon from being pushed away from the LAA         ostium.     -   The third balloon, which is located on the outer sheath, is         inflated within the left atrial cavity adjacent to the LAA         ostium and is pushed towards the LAA ostium. Thus, the inflated         third balloon envelops the LAA ostium. The inflated first and         third balloons are manually pushed towards each other by pulling         on the inner sheath and pushing on the outer sheath.     -   Aspects of the present disclosure guard against the possibility         of the inflated first balloon falling out of the LAA and into         the left atrial cavity. In particular, the inflated third         balloon has an additional function of preventing the inflated         first balloon from falling into the left atrial cavity         especially in the setting of an indistinct LAA ostium where a         constriction is absent. Additionally, a locking mechanism is         described where the inner and outer sheaths lock on to each         other. This locking mechanism may be present intravascular,         intracardiac, or outside the body. In addition, an additional         inflatable balloon that is attached to the outer sheath can be         inflated immediately to the left of the interatrial septum to         render the outer sheath stationary.

The LAA ostium has an oval shape. Applying a circumferential tie or suture to the LAA ostium is going to compress a fixed circumference to a smaller area and therefore will cause puckering. Puckering is more likely to cause gaps and incomplete occlusion. A suture is also more likely to cause tears in the LAA especially in elderly hearts. A closure device that approximates the opposing surfaces is a better approach and is unlikely to cause puckering. Embodiments of the present disclosure present a novel closure device that approximates surfaces opposite to each other and brings them into contact is a better approach. This is most effectively created by applying forces along the short axis or short diameter of the oval or elliptical ostium. Hence, a barrette or clip applied at the ostium of the LAA is more likely to seal off the structure. Force applied along the long diameter is less likely to approximate the opposite surfaces since (a) the two surfaces will have to travel a longer distance and (b) a greater amount of force will be necessary to overcome the intrinsic tissue elasticity.

-   -   Creating endothelial denudation at the LAA ostium by intentional         injury will create inflammation and cross-linking of collagen         fibers, resulting in more durable occlusion of the LAA ostium.         Aspects of the present disclosure provide such a feature. For         example, endothelial denudation at the LAA ostium can be created         by application radiofrequency (RF) current via the inflatable         balloons at the LAA ostium.

The Concept of Counter-Pressure.

-   -   A logical extension of the above methods is whether the same         concept and method can also be used to penetrate the LAA and         place a conduit into the structure to allow for various         interventions performed on the heart. In this situation, the LAA         is pierced in the opposite direction, i.e. from the pericardial         space that has been accessed previously using a surgical         approach. The cannula that is inserted into the LAA has an         expandable element such as a balloon with suction or magnetic or         electromagnetic elements attached to its wall.     -   With epicardial surgical cannulation of the LA appendage and a         subsequent inflation of a balloon within the LA appendage, a         system of multiple balloons or expanding elements that adhere to         each other with one balloon inflated within the left atrial         cavity (and thus trying to achieve a tight seal across the         ostium of the appendage) may not be necessary. This may be         because since the operator has ready access to the pericardial         cavity and the epicardial surface of the left atrium appendage,         after inflating the balloon, pressure can be applied with a         constricting device or loop from the epicardical surface. Or,         “counter-pressure” can be applied in a circumferential manner         from an outer sheath. The term counter-pressure refers to         pressure applied in one direction to counter balance pressure         from another. Hence, the wall of the left atrial appendage may         be compressed in a circumferential manner from both the         endocardial and epicardial directions.     -   The wall of the LAA tends to be extremely thin. While attempting         to pierce this wall, the wall may invaginate. The subsequent         puncture may therefore occur in an oblique fashion and may         result in a tear or laceration rather than a focused and sharply         limited perforation. In order to cannulate the wall, it is         critical to hold it fixed and prevent invagination during         piercing of the structure. It is preferable that perforation of         the structure occur perpendicular to the left atrial wall rather         than in an oblique manner. To facilitate this, the piercing         element may be inserted through a tube and attached to the         circumference of this outer tube, may be a plurality of suction         elements. In a preferred embodiment, no suction will be applied         through the main lumen of the tube via which the piercing         element is advanced.

SUMMARY OF THE DISCLOSURE

Aspects of the present disclosure address the foregoing needs with novel methods and systems for accessing a pericardial space and preventing strokes arising from the LAA by achieving a complete occlusion of the LAA using an epicardial approach without creating a puckering of the LAA ostium. The contents of this summary section are provided only as a simplified introduction to the disclosure, and are not intended to be used to limit the scope of the appended claims.

In an exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, wherein the tissue-penetrating tip is a sharpened tip capable of puncturing (a) a wall of the LAA, and (b) a wall of a pericardial cavity, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, wherein the tissue-penetrating tip is a sharpened tip capable of puncturing (a) a wall of the LAA, and (b) a wall of a pericardial cavity, wherein the tissue-penetrating tip further has a RF electrode delivering RF current that can puncture (a) a wall of the LAA, and (b) a wall of a pericardial cavity, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons, wherein at least one inflatable balloon of the inner sheath has a first set of electromagnetic coils or magnetic elements, wherein the first set of electromagnetic coils expands within the balloon upon inflation of the balloon, and wherein at least one inflatable balloon of the outer sheath has a second set of electromagnetic coils, wherein the second set of electromagnetic coils expands within the balloon upon inflation of the balloon; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment of the present disclosure, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes, and wherein the closure device further comprises hydrogel coated over at least an inner surface of the pair of semi-rigid hollow tubes.

In another exemplary embodiment of the inventive system, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes, and wherein the closure device further comprises silicone gel coated over at least an inner surface of the pair of semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons; the outer sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons, wherein at least one balloon serves as an anchor; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons that are coated with biocompatible hydrogel; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon, wherein at least one balloon serves as an anchor; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons having sponges attached to the exterior of each balloon; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon, wherein at least one balloon serves as an anchor; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon having caliber tubes attached to the exterior of the balloon, wherein at least one balloon serves as an anchor; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons; the outer sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons, wherein at least one balloon serves as an anchor, and at least one balloon has caliber tubes attached to the exterior of the balloon; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In another exemplary embodiment, the present disclosure includes a system comprising a catheter having an inner sheath, an outer sheath, and an inner catheter; the inner sheath having a distal end and a proximal end, wherein the distal end has at least two inflatable balloons and at least one radiopaque marker band; the outer sheath having a distal end and a proximal end, wherein the distal end has at least one inflatable balloon; the inner catheter having a distal end and a proximal end, wherein the distal end has a tissue-penetrating tip, wherein the tissue-penetrating tip, and wherein the proximal end has at least one inflatable balloon serving as an anchor; locking means to lock the inner sheath and the outer sheath; an inflation port; a control port; and a closure device having a suture looped around at least two semi-rigid hollow tubes.

In an exemplary embodiment, a method of the present disclosure comprises the steps of: (1) introducing catheter into a body cavity, the catheter having an inner sheath, an outer sheath, and an inner catheter; (2) advancing a distal end of the inner sheath to position the distal end of the inner sheath in an interior of an LAA; (3) inflating a first inflatable balloon, wherein the first balloon is on the distal end of the inner sheath, and wherein the first balloon is inflated within the LAA interior adjacent to an ostium of the LAA; (4) pulling the inflated first balloon in a direction from within the LAA interior and towards the LAA ostium; (5) inflating a second inflatable balloon, wherein the second balloon is on the distal end of the inner sheath, wherein the second balloon is inflated within a distal portion of the LAA interior, and wherein upon inflation, the inflated second balloon pushes the inflated first balloon towards the LAA ostium; (6) advancing a distal end of the outer sheath to position the distal end of the outer sheath in a portion of the left atrium adjacent to the LAA ostium; (7) inflating a third inflatable balloon, wherein the third balloon is on the distal end of the outer sheath, and wherein the third balloon is inflated within a portion of the left atrium adjacent to the LAA ostium; (8) pushing the inflated third balloon in a direction from within the left atrium portion adjacent to the LAA ostium and towards the LAA ostium; (9) activating a locking mechanism to lock the inner sheath to the outer sheath, thereby rendering stationary the inflated balloons; (10) advancing a distal end of the inner catheter to position a distal end of the inner catheter within a distal portion of the LAA interior near an apex of the LAA; (11) puncturing a wall of the LAA interior near or at the LAA apex using a tissue-penetrating tip on the distal end of the inner catheter; (12) advancing the distal end of the inner catheter into the pericardial cavity and through the pericardial cavity to the desired site of exteriorization; (13) puncturing a wall of the pericardial cavity at the desired site of exteriorization; (14) externalizing the inner catheter out of the pericardial cavity at the desired site of exteriorization, wherein the inner catheter can be externalized or “pushed out” with a combination of manual force, electromagnetic force, and/or radio frequency energy delivery; (15) advancing a proximal end of the inner catheter to the distal portion of the LAA interior near the LAA apex; (16) inflating a fourth inflatable balloon, wherein the fourth balloon is on the proximal end of the inner catheter, and wherein the fourth balloon is inflated within the distal portion of the LAA interior near the LAA apex; (17) pulling the inflated fourth balloon in a direction from within the distal portion of the LAA interior near the LAA apex and towards the pericardial cavity to anchor the LAA; (18) advancing an LAA closure device to the LAA ostium via the externalized inner catheter and positioning the LAA closure device over the exterior of the LAA ostium; (19) deploying the LAA closure device over the exterior of the LAA ostium; and (20) injuring at least a portion of an interior surface of the LAA ostium to promote occlusion of the LAA.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. At steps (3) and (7), the first and third inflatable balloons each have a set of electromagnetic coils or magnetic elements located within. Upon inflation of these balloons, the respective sets of electromagnetic coils also expand within the respective balloon. The expansion of the electromagnetic coils creates electromagnetic forces that attract the first and third inflated balloons towards each other.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. At steps (3) and (5), the first and second inflatable balloons have biocompatible hydrogel coated to the exterior of each balloon. Upon inflation of these balloons, the biocompatible hydrogel expands on contact with fluid, such as blood.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. At step (7), the third inflatable balloon has caliber tubes attached to its exterior. These tubes will allow for the application of vacuum or suction forces to the left atrial tissue or to the surface of the adjacent balloon to provide for a tighter hemostatic seal.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. At steps (11) and (13), the tissue-penetrating tip is a sharpened tip capable of puncturing (a) the wall of the LAA, and (b) the wall of the pericardial cavity. The penetrating tip may further comprise a RF electrode delivering RF current sufficient to puncture (a) the wall of the LAA, and (b) the wall of the pericardial cavity.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. At steps (12) to (14), the desired site of exteriorization is at the junction of the abdomen and thorax and below the ribs near a base of the sternum called a xiphisterum so that the inner catheter follows a subxiphoid path.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. At steps (12) to (14), the desired site of exteriorization is at the junction of the abdomen and thorax and below the ribs near a base of the sternum called a xiphisterum so that the inner catheter follows a subxiphoid path. In other exemplary embodiments, the desired sites of exteriorization include the right pectoral regions, the left pectoral regions, or any other region higher up in the chest, lateral to the sternum between the ribs.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. At step (14), the inner catheter can be “pulled out” from the pericardial cavity with electromagnetic forces applied with another catheter having an electromagnetic probe that is placed at the desired site of exteriorization. A small incision can be made in the skin to the left of the xiphisternum, or higher up in the chest, for example, lateral to the sternum between the ribs. An electromagnetic probe is introduced towards the pericardial cavity through this incision to attract the inner catheter (that has electromagnets incorporated) that is then exteriorized. The distal end of the inner catheter would comprise an electromagnetic element, which interacts with the electromagnetic probe adapted to draw the inner catheter out of the pericardial cavity.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. At step (19), the closure device may be coated over at least an inner surface with a hydrogel, silicone gel, and/or other biocompatible material. Hydrogels will expand on contact with fluid, such water or blood, to further compress the LAA ostium.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. Between steps (08) and (09) is an additional step, wherein this step includes inflating an additional balloon within a portion of the left atrium adjacent to the interatrial septum to render stationary the outer sheath. This additional balloon is on the distal end of the inner sheath and serves to anchor in-place the outer sheath and the other inflated balloons. Alternatively, this additional balloon can inflated adjacent the fossa ovalis. Optionally, a locking mechanism can be activated to render stationary the outer sheath and this inflated additional balloon adjacent to the interatrial septum. This locking mechanism can be deployed after the inflation of this additional balloon but before step (09). The locking mechanism would be similar to the one deployed in step (09).

In another exemplary embodiment, a method of the present disclosure further comprises the following features. For brevity, steps (1)-(20) of the exemplary embodiment of the present disclosure's method are incorporated herein. After step (20), this alternate exemplary embodiment further includes the steps of: deflating the first inflated balloon, deflating the second inflated balloon, deflating the third inflated balloon, deactivating the locking mechanism, removing the outer sheath from the body cavity, and removing the inner sheath from the body cavity.

In another exemplary embodiment, a method of the present disclosure further comprises the following features. Unlike the method described above, the LAA is pierced in the opposite direction, i.e. from the pericardial space that has been accessed previously using a surgical approach (as shown in FIGS. 21-30), to safely insert a cannula or conduit into the heart via the LAA. FIGS. 22 and 23 show an insertion of a plurality of hollow tubes where an inner and outer tubes can slide over each other. Inflatable balloons are attached to these tubes. The balloons may be inflated in such a way that one balloon is inflated within the left atrial cavity while the other is inflated within the LAA. The sheaths are then slid over each other so that the balloons are now pulled towards each other. In addition, the balloons are attracted towards each other to produce a seal of the LAA ostium using magnetic, electromagnetic or suction forces. Thus, the tube inserted into the LAA serves as a conduit through which any additional tools or materials can be inserted into the heart.

In another exemplary embodiment, a method of the present disclosure comprises the following features. The wall of the LAA tends to be extremely thin. While attempting to pierce this wall, the wall may invaginate (seen as a dashed line in FIG. 24). The subsequent puncture may therefore, may occur in an oblique fashion and may result in a tear or a laceration rather than as a focused and sharply limited perforation. In order to pierce the wall optimally, it is critical to hold it fixed and prevent invagination during piercing of the structure (the taut and fixed LAA wall is shown as 2504 in FIG. 27A). FIG. 25 shows a suction cannula that applies suction to the LAA wall with a piercing element that is within the suction cannula. In this exemplary embodiment, it is preferable that perforation of the structure occur perpendicular to the left atrial wall rather than in an oblique manner. However, the design shown in FIG. 25 may be problematic. The thin wall of the appendage may get sucked into the cannula in the form or a nipple, bleb or bubble. The wall may get pierced in an oblique and suboptimal fashion. To facilitate a focused puncture rather than a tear or a laceration, the piercing element will inserted through a tube and attached to the circumference of this outer tube, will be a plurality of suction elements (shown in FIGS. 27A-C) which will keep the LAA wall taut (2504 in FIG. 27A) and prevent it from getting sucked into the tube that houses the piercing element. In a preferred embodiment, no suction will be applied through the main lumen of the tube (2708) via which the piercing element (2102) is advanced. It is also expected that the surface of the balloon upon inflation within the LAA (seen as 2802 in FIGS. 28; 2904 and 2906 in FIG. 29; and as 3002 in FIG. 30) will have tubes attached to it to apply suction.

FIG. 26 represents an outer sheath that will be used to provide counter-pressure. Application of counter-pressure where the inflated balloon within the LAA is pulled back while the outer sheath is pushed forward, is described in greater detail in regard to FIGS. 28 and 29. A suction device includes a sheath 2602 that extends over the suction tube 2502 and has a greater diameter and will be advanced forward towards the LAA as the tip is pulled back by suction forces applied by the suction application tube. The sheath 2602 may include an end 2510 that is configured to be placed against the outer surface of the LAA 2406 to apply the suction force. The additional diameter of the sheath 2602 by enveloping the puncture may provide for additional control of the LAA during puncture by the tip 2402.

The embodiments shown in FIGS. 25-27 may provide for additional control of the LAA wall during puncture of the LAA, and reduction of undesired tearing or laceration of the structure and bleeding of the LAA. The systems and methods disclosed in regard to FIGS. 25-27 may be incorporated into any system or method disclosed in this application or in U.S. patent application Ser. No. 14/941,457.

In another exemplary embodiment, a method of the present disclosure comprises the following features. The cannula that is inserted into the LAA has an expandable element such as a balloon with suction or magnetic or electromagnetic elements attached to its wall.

With epicardial surgical cannulation of the LA appendage and a subsequent inflation of a balloon within the LA appendage, a system of multiple balloons or expanding elements that adhere to each other with one balloon inflated within the left atrial cavity (and thus trying to achieve a tight seal across the ostium of the appendage) may not be necessary. This is because since the operator has ready access to the pericardial cavity and epicardial surface of the left atrium appendage, after inflating the balloon, pressure can be applied with a constricting device or loop from the epicardial surface. Or, “counter-pressure” can be applied in a circumferential manner from an outer sheath. The term counter-pressure refers to pressure applied in one direction to counter balance pressure from another. Hence, the wall of the left atrial appendage may be compressed in a circumferential manner from both the endocardial and epicardial directions. The endocardial pressure will be applied by the inflated balloon that after inflation, is pulled backwards towards the point of entry (shown in FIGS. 28 and 29). FIG. 28 illustrates an embodiment of the present disclosure in which an inflatable balloon 2802 is inflated within a cavity of the LAA 2406. The inflatable balloon 2802, upon inflation and pulling back towards the entry point, may apply pressure against an interior or endocardial surface of the LAA. The pressure applied by the inflatable balloon 2802 may be applied in a direction towards the exterior of the LAA. Similarly, in FIG. 29, the balloon that has a strawberry shape (2904 and 2906) is inflated and is pulled back towards the entry point. The pressure applied by the inflatable balloon may be provided by the pressure of inflation, or may be provided by a force caused by the sheath 2804 being drawn in a direction towards the exterior of the LAA. A pressure applicator device that applies pressure on the outer or epicardial surface is shown as 2808 in FIG. 28 and as 2908 in FIG. 29. The epicardial pressure applicator may be used to apply pressure to the LAA in a direction opposite to the pressure applied by the inflatable balloons. The pressure applicator device 2808 may be pushed towards the LAA wall. The pressure applicator device 2808 may comprise a sleeve or other form of pressure applicator device that is configured to apply pressure to the outer surface of the LAA. In the embodiment shown in FIG. 28, the pressure applicator device 2808 may have a funnel shape configured to contour to the shape of the LAA. The funnel shape may increase the area over which pressure is applied. In one embodiment, the pressure applicator device, and/or the inflatable balloon may have shapes that complement each other as shown in FIG. 29. For example, in one embodiment, the inflatable balloon may have a conical shape and the pressure applicator device may have a funnel shape.

The pressure applicator device 2808 may be coupled or attached to the sheath 2804. A locking mechanism 2810, such as a spring locking mechanism disclosed in this application may be used to maintain the forces provided by both the inflatable balloon 2802 and the pressure applicator device 2808. The locking mechanism 2810 may be used to hold and lock the inflatable balloon and the pressure applicator device in position relative to each other.

The pressures applied by the inflatable balloon 2802 and the pressure applicator device 2802 may comprise counter-pressures. The pressures are applied in opposite directions and thus counter balance each other. The compressive force may serve to seal the LAA ostium, and/or prevent bleeding from the wall of the LAA.

As shown in FIGS. 28 and 29, a pressure may be applied to both sides of the LAA, in a circumferential manner, near the puncture site. Hemostasis may be desirably maintained effectively within the LAA. FIG. 29 illustrates an embodiment of a pressure being applied by an inflatable balloon 2902 in a similar manner as disclosed in regard to the embodiment of FIG. 28. The LAA is entered from a surgically accessed exterior/pericardial space. The inflatable balloon 2902, however, has a first portion 2904 and a second portion 2906. The first portion 2904 may have a different degree of compliance than the second portion 2906 and has a wider diameter.

The pressure applicator device 2908 in FIG. 29 may have a funnel shape to complement the conical shape of the second portion of the expanding element 2906. The pressure applicator device 2908 may be pressed against the outer surface of the LAA wall, and the inflatable balloon may be inflated to provide a pressure against the inner surface of the LAA wall, or may be drawn towards the inner surface of the LAA wall. An effective counter pressure may be provided in the embodiment of FIG. 29 that is achieved over a larger area than shown in regard to the embodiment of FIG. 28. To increase the effectiveness of preventing bleeding across the entry site, the inflatable balloon may have suction tubes along its inflated surface to improve adhesion of the balloon surface with the endocardial wall of the LAA.

In another exemplary embodiment, a method of the present disclosure comprises the following features. FIG. 30 shows an example of counter-pressure where the epicardial pressure is exerted circumferentially in a constricting manner along a preselected zone. In this embodiment, epicardial pressure is not exerted around the entry site of the LAA. In this Figure, inflatable balloon 3002 is inflated within a cavity of the LAA 2406. The LAA is entered from a surgically accessed exterior/pericardial space. The inflatable balloon 3002 may be coupled to a sheath 3004. The inflatable balloon 3002 may include an indentation 3006. The indentation 3006 may have the form of a groove that extends circumferentially around the balloon 3002. The indentation 3006 may be pre-formed into the inflatable balloon 3002 and serves to prevent the circumferential tie or constriction from dislodging.

In another exemplary embodiment, a method of the present disclosure comprises the following features. FIG. 31 illustrates an embodiment of the present disclosure in which suction devices are utilized with one or more of the inflatable balloons 102, 104, 115. The suction devices may take the form of tubes 3102 that are coupled to one or more of the inflatable balloons 102, 104, 115. The suction devices may be configured to provide a suction force. The suction force may be used to attract any of the balloons 102, 104, 115 to each other, or may be used to attract any of the balloons to an interior surface of the LAA. In one embodiment, the suction devices may be used as a substitute for the electromagnetic coils disclosed in this application.

BRIEF DESCRIPTION OF THE DRAWINGS

Other systems, methods, features and advantages of the present disclosure will be, or will become, apparent to one of ordinary skill in the art upon examination of the following figures and detailed description. It is intended that all such additional apparatuses, systems, methods, features and advantages be included within this description, be within the scope of the present disclosure, and be protected by the appended claims. Component parts shown in the drawings are not necessarily to scale, and may be exaggerated to better illustrate the important features of the present disclosure. In the drawings, like reference numerals designate like parts throughout the different views, wherein:

FIG. 1 is a perspective view of an exemplary embodiment of a catheter, which is part of present disclosure's system for accessing a pericardial space and preventing strokes arising from the LAA.

FIG. 2 is a perspective view of the locking means of the exemplary embodiment of FIG. 1.

FIG. 3 is a flowchart depicting an exemplary embodiment of the present disclosure's method for accessing a pericardial space and preventing strokes arising from the LAA.

FIG. 4 is a first perspective view depicting the initial steps of the exemplary embodiment of FIG. 3.

FIG. 5 is a second perspective view depicting the initial steps of the exemplary embodiment of FIG. 3.

FIG. 6 is a third perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 6 illustrates the advancement of the inner catheter through the wall of the LAA and into the pericardial cavity surrounding the heart.

FIG. 7 is a fourth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 7 illustrates the further advancement of the inner catheter through the pericardial cavity and into a region adjacent to the xiphisternum.

FIG. 8A is a fifth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 8A illustrates the inner catheter being “pulled out” and exteriorized by way of electromagnetic forces.

FIG. 8B illustrates alternative sites for exteriorizing the inner catheter after it has been drawn from the pericardial cavity.

FIG. 9 is a sixth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 9 shows the deployment of the closure device being advanced over the exteriorized inner catheter and to the exterior of the LAA ostium.

FIG. 10 illustrates a prior art closure device employing a loop or suture which results in puckering of the LAA ostium.

FIG. 11 is a seventh perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 9 illustrates the deployment of the closure device being deployed over the exterior of the LAA ostium without creating a puckering of the LAA ostium.

FIG. 12 is an eighth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 12 illustrates the injury of the inner surface of the LAA prior to closure, where the injury causes an injury response which results in a more complete sealing along the opposed tissue surfaces.

FIG. 13 illustrates a closure device of the present disclosure, which is part of present disclosure's system for accessing a pericardial space and preventing strokes arising from the LAA.

FIG. 14 is a ninth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3.

FIG. 15 is a photo depicting an exemplary anatomy of an LAA.

FIG. 16 is an exemplary depiction of an LAA showing the presence of distinct protrusions within the LAA termed lobes.

FIG. 17 is an exemplary depiction of an LAA in accordance with the hour-glass concept.

FIG. 18 is another exemplary depiction of an LAA in accordance with the hour-glass concept which also displays the lobes, crypts and crevices of the LAA.

FIG. 19 is a tenth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 19 illustrates the accentuation of the waist of the LAA ostium and the wall of the proximal portion of the LAA caused by the inflation of the non-compliant balloon.

FIG. 20 is a perspective view depicting an optional step of the exemplary embodiment of FIG. 3.

FIG. 21 illustrates a perspective view of a tissue penetrating tip entering the LAA through a wall of the LAA.

FIG. 22 illustrates a perspective view of the tissue penetrating tip of FIG. 21 extending into the LAA with a balloon inflated in the left atrial cavity and is pulled back towards the LAA.

FIG. 23 illustrates a perspective view of at least one balloon inflated within the LAA.

FIG. 24 illustrates a perspective view of an invagination of the LAA.

FIG. 25 illustrates a perspective view of a tissue penetrating tip entering the LAA through a wall of the LAA.

FIG. 26 illustrates a perspective view of a tissue penetrating tip entering the LAA through a wall of the LAA.

FIG. 27A illustrates a perspective view of a suction device contacting a wall of a LAA.

FIG. 27B illustrates a perspective view of the suction device of FIG. 27A.

FIG. 27C illustrates a front view of the end of the suction device of FIG. 27A.

FIG. 28 illustrates a perspective view of an inflatable balloon inflated within the LAA.

FIG. 29 illustrates a perspective view of an inflatable balloon inflated within the LAA.

FIG. 30 illustrates a perspective view of an inflatable balloon inflated within the LAA with a constricting tie placed thereon.

FIG. 31 illustrates a perspective view of a plurality of inflatable balloons inflated within the LAA with suction devices.

FIG. 32 illustrates a perspective view of a plurality of inflatable balloons inflated within the LAA with at least one suction device.

FIG. 33 illustrates a perspective view of a closure device positioned over the ostium of a LAA.

FIG. 34 illustrates a perspective view of a closure device positioned over the ostium of a LAA.

FIG. 35 illustrates a perspective view of a closure device positioned over the ostium of a LAA with a plurality of inflatable balloons having been withdrawn from the LAA cavity.

FIG. 36 illustrates a perspective view of a plurality of inflatable balloons positioned within the LAA cavity and including magnetic responsive materials.

DETAILED DESCRIPTION OF THE DISCLOSURE

FIG. 1 is a perspective view of an exemplary embodiment of a catheter 100, which is part of aspects of the present disclosure's system for accessing a pericardial space and preventing strokes arising from the LAA. The present disclosure's system also includes closure device 1300, as shown in the exemplary embodiment of FIG. 13. FIG. 1 shows a stand-alone catheter 100 before it is introduced into a body cavity and thus, FIG. 1 shows inflatable balloons 102, 104, 115 and 119 in their un-inflated form. Inflatable balloon 104 is attached to an outer sheath 103. Inflatable balloons 102 and 115 are attached to inner sheath 101. Inflatable balloon 119 is attached to inner catheter 117. Depending on the desired degree of compliance, inflatable balloons 102, 104, 115 and 119 can be made of rubber, latex, polyisoprene, silicone, polyurethane, or any combination thereof. Rubber, latex, polyisoprene, and silicone produce more compliant inflatable balloons. Polyurethane produces non-compliant inflatable balloons. For non-compliant balloons, a higher pressure is ideal when inflating such balloons. A mixture of silicone and polyurethane produces half-way compliant inflatable balloons.

A more compliant balloon will assume the contours of its surroundings when inflated. By contrast, a non-compliant balloon will expand the contours of its surroundings when inflated. In this exemplary embodiment of FIG. 1, inflatable balloons 104 and 115 are more compliant and thus, when inflated, each assumes the contours of its surroundings, as shown in FIG. 4. Thus, inflated balloon 104 will assume the shape of the smooth-walled left atrial cavity, whereas inflated balloon 115 will assume the shape of the rough-walled LAA. In particular, inflated balloon 115 can cover the potential sites of tear and bleeding, such as the lobes and recesses within the LAA walls.

By contrast, inflatable balloon 102 is non-compliant and thus, when inflated, it expands the contours of its surrounding. As shown in FIG. 4, an inflated balloon 102 expands the contours of the LAA wall. By expanding the contours of its surroundings, inflatable balloon 102 accentuates the waist of the LAA ostium and the walls of the proximal portions of the LAA, as shown in FIG. 19. The ability of inflatable balloon 102 to accentuate the waist of the LAA ostium is an important feature because it prevents inflatable balloon 102 from falling into the left atrial cavity, which is particularly important because a distinct constriction is often absent at the LAA ostium. The application of electromagnetic or magnetic or suction forces will also result in inflated balloon 104 making a better contact with the smooth-wall left atrium cavity wall. Moreover, the ability of inflatable balloon to accentuate the LAA walls also helps cover the potential sites of tear and bleeding, such as the lobes and recesses within the LAA walls.

Optionally, inflatable balloons 102 and 115 can each have biocompatible hydrogel coated to its exterior (not illustrated in FIG. 1). Biocompatible hydrogel expands upon contact with fluid, such as blood or water. By absorbing the surrounding fluid, such as blood, the hydrogel helps to inhibit bleeding from the left atrium to the pericardial cavity, or from the LAA into the pericardial cavity. Alternatively, inflatable balloons 102 and 115 can each have sponges attached to its exterior (not illustrated in FIG. 1). The sponges will expand upon contact with fluid, such as blood or water. Like the hydrogel, the purpose of the sponges is to absorb surrounding fluid, such as blood, thereby inhibiting bleeding from the left atrium to the pericardial cavity, or from the LAA into the pericardial cavity.

Inflatable balloon 119 serves to anchor the LAA while (a) a closure device is being deployed to the LAA, and (b) the deflation of the inflated balloons if desired. Hence, inflatable balloon 119 can be termed the anchoring balloon.

Optionally, an additional inflatable balloon can be attached to the distal end of outer sheath 103 (not shown in FIG. 1). This additional inflatable balloon serves as an anchor and thus, is similar to inflatable balloon 119. This additional anchoring balloon prevents outer sheath 103 from being pulled back, and thus, keeps inflatable balloon 104 in-place. As shown in FIG. 20, this additional anchoring balloon can be inflated adjacent to the fossa ovalis or the interatrial septum, as shown in FIG. 20.

Despite the foregoing, it is contemplated that inflatable balloons 102, 104, 115 and 119 can each be compliant, semi-compliant, non-compliant, or any combination of the foregoing, depending on design needs. Additionally, it is contemplated that catheter 100 can be made up of more than four inflatable balloons depending on design needs.

Inflatable balloon 104 can be inflated with the input of air, or a suitable liquid material, such as saline, via inflation port 112 through outer sheath openings 106 a, 106 b, and 106 c. Optionally, the suitable liquid material can be mixed with radiopaque contrast to provide spatial guidance. It is contemplated that the number of outer sheath openings can vary depending on design needs. For example, inflatable balloon 104 can be inflated via inflation port 112 through only one outer sheath opening, or through more than three outer sheath openings.

Inflatable balloons 102 and 115 can each be inflated with the input of air, or a suitable liquid material, such as saline, via inflation port 112 through inner sheath openings 105 a, 105 b, and 105 c, and 116 a, 116 b, and 116 c, respectively. Optionally, the suitable liquid material can be mixed with radiopaque contrast to provide spatial guidance. It is contemplated that the number of inner sheath openings can vary depending on design needs. For example, inflatable balloons 102 and 115 can each be inflated via inflation port 112 through only one inner sheath opening, or through more than three inner sheath openings.

Inflatable balloon 119 can be inflated with the input of air, or a suitable liquid material, such as saline, via inflation port 112 through inner catheter opening 120. Optionally, the suitable liquid material can be mixed with radiopaque contrast to provide spatial guidance. It is contemplated that the number of catheter openings can vary depending on design needs. For example, inflatable balloon 119 can be inflated via inflation port 112 through more than one inner catheter opening.

Inflation port 112 provides the portal for the input of air by, or a suitable liquid material, such as saline, by, for example, a balloon catheter inflation device commonly known to one skilled in the art. Optionally, the suitable liquid material can be mixed with radiopaque contrast to provide spatial guidance.

When inflated, inflatable balloon 104 has a larger diameter than that of the LAA ostium, as shown in FIG. 4. By having a larger diameter than that of the LAA ostium, inflatable balloon 104 is able to form an effective hemostatic seal, and effectively occlude the LAA ostium. Optionally, inflatable balloon 104 can have caliber tubes attached to its exterior. These tubes will allow for the application of vacuum or suction forces to the left atrial tissue or to the surface of the adjacent balloon to provide for a tighter hemostatic seal.

Optionally, catheter 100 can include electromagnetic coils. Electromagnetic coils can provide further support for firmly occluding the LAA ostium. In this exemplary embodiment of FIG. 1, electromagnetic coils 114 are located within inflatable balloon 103, and electromagnetic coils 113 are located within inflatable balloon 102. When inflatable balloons 103 and 102 are inflated, electromagnetic coils 113 and 114 also expand within the respective balloon, as shown in FIG. 4. Electromagnetic coils 113 and 114 are insulated wires coiled together to form a solenoid, and thus, can be made out of copper or any other metallic wire capable of conducting electricity. In addition, catheter 100 can also include magnetic elements where one element is a magnet and the other element is a magnet or has a metallic component that is attracted to a magnet.

The distal end of inner catheter 117 has tissue-penetrating tip 118 adapted to penetrate the LAA wall and the pericardial sac. Tissue-penetrating tip 118 can be a blunt or sharpened tip, and/or an RF electrode delivering RF current, to puncture the LAA wall tissue and optionally the pericardial sac tissue when optionally advanced out of the pericardial space as described below.

Optionally, the distal end of inner catheter 117 may include an electromagnetic element. This electromagnetic element interacts with an electromagnetic probe adapted to draw inner catheter 117 out of the pericardial cavity.

As duly noted by elongation identifier 121, the length of inner catheter 117 can vary depending on the body cavity dimension of the particular patient. As duly noted by elongation identifier 111, the length of inner sheath 101 can vary depending on the body cavity dimensions of the particular patient. Similarly, as duly noted by elongation identifier 122, the length of outer sheath 103 can vary depending on the body cavity dimensions of the particular patient.

Optionally, catheter 100 can include radiopaque marker bands. As shown in the exemplary embodiment of FIG. 1, radiopaque marker bands 107 a and 107 b are thin metal tubes placed along inner sheath 101 to provide spatial guidance under an X-ray fluoroscope. Inner sheath 101 is introduced into the body cavity, and advanced until radiopaque marker band 107 b reaches the mid-point of the LAA ostium, as shown in FIG. 2. When radiopaque marker band 107 b reaches the mid-point of the LAA ostium, inflatable balloon 102 is inflated. Moreover, radiopaque marker band 107 b provides guidance for advancing outer sheath 103. In particular, outer sheath 103 is introduced into the body cavity and advanced through the body cavity until outer sheath 103 reaches radiopaque marker band 107 b.

After balloons 102, 104, and 115 are inflated, locking means 109 is activated. Locking means 109 is shown in FIG. 2. Locking means 109 is a spring-loaded device housed in inner sheath 101 that, upon activation, the protrusions would bulge out through the corresponding protrusion slots on outer sheath 103, as shown in FIG. 2. These protrusions and corresponding protrusion slots can be of varying dimensions. The purpose of locking means 109 is to render stationary inflated balloons 102 and 104 so that the hemostatic seal is firmly occluding the LAA ostium.

Optionally, an additional locking mechanism similar to locking means 109 can be present on outer sheath 103 (not illustrated in FIG. 1). This additional locking mechanism would be used to render stationary (a) an additional anchoring balloon inflated within the left atrium adjacent to the interatrial septum, and (b) outer sheath 103. Like locking mechanism 109, this additional locking mechanism would be a spring-loaded device housed in inner sheath 101 that, upon activation, the protrusions would bulge out through the corresponding protrusion slots on outer sheath 103, as shown in FIG. 2. These protrusions and corresponding protrusion slots can be of varying dimensions.

Control port 110 provides the portal for connection to catheter handling devices designed to control and navigate inner sheath 101, outer sheath 103, and inner catheter 117 to the desired locations. Inner sheath 101, outer sheath 103, and inner catheter 117 can also be steerable such that each are deflectable with pull wire technology or other methods to allow for the respective tips to be deformed in the desired direction.

FIG. 2 is a perspective view of the locking means in the exemplary embodiment of FIG. 1. Locking means 109 is a spring-loaded device housed in inner sheath 101 that, upon activation, the protrusions would bulge out through the corresponding protrusion slots on outer sheath 103. These protrusions and corresponding protrusion slots can be of varying dimensions. The purpose of locking means 109 is to render stationary inflated balloons 102 and 104 so that the hemostatic seal is firmly occluding the LAA ostium.

FIG. 3 is a flowchart depicting an exemplary embodiment of the present disclosure's method for accessing a pericardial space and preventing strokes arising from the LAA. At step 301, catheter 100 is introduced into a body cavity. Typically, catheter 100 can be introduced in the body cavity via a puncture. Catheter 100 can be introduced into different body cavities, such as via a femoral vein, a jugular vein, an axillary vein, or a subclavian vein. Alternatively, catheter 100 can also be introduced directly into the chambers of the heart via introduction at the right atrium and advanced to the left atrium, as shown in FIGS. 5-7. In yet another embodiment, catheter 100 can be introduced directly into the chambers of the heart via introduction at the apex of the left ventricle. As shown in FIG. 1, catheter 100 comprises inner sheath 101, outer sheath 103, and inner catheter 117, among other components.

At step 302, inner sheath 101 is advanced to position a distal end of inner sheath 101 within an interior of the LAA. As shown in FIGS. 4-5, inner sheath 101 can be advanced to position its distal end within the LAA interior via a left atrium. Inner sheath 101 (as well as outer sheath 103 at step 306 and inner catheter at step 310) may be advanced to the left atrium by any known technique, including transseptal delivery where the left atrium is accessed from the right atrium, thorascopic delivery, via a retrograde transaortic approach, and the like. Optionally, catheter 100 may comprise radiopaque marker bands, such as radiopaque marker band 107 a and 107 b, which can provide spatial guidance for positioning the distal end of inner sheath 101 within the LAA interior.

At step 303, inflatable balloon 102 is inflated within an interior of the LAA adjacent to the LAA ostium, as shown in FIG. 4. Inflatable balloon 102 can be inflated with the input of air, or a suitable liquid material, such as saline, via inflation port 112 through inner sheath openings 105 a, 105 b, and 105 c. Optionally, the suitable liquid material can be mixed with radiopaque contrast to provide spatial guidance. Inflatable balloon 102 is inflated with high occlusive pressures because it is a non-compliant balloon. Because inflatable balloon 102 is non-compliant, it expands the contours of its surrounding when inflated. The LAA is distensible and hence should readily deform in response to high pressure inflation with non-compliant balloon 102. Thus, as shown in FIG. 19, non-compliant balloon 102 accentuates the waist of the LAA interior adjacent to the LAA ostium to prevent an inflated non-compliant balloon 102 from falling into the left atrium, which is particularly important because a distinct constriction is often absent at the LAA ostium. Additionally, due to the presence of deep crypts or recesses in-between the pectinate muscles and the presence of protrusions or lobes in the LAA interior, as shown in FIGS. 16, 18-19, an inflated non-compliant balloon 102 also accentuates these crypts, recesses, protrusions, and lobes. Therefore by expanding the contours of its surroundings in the LAA interior, non-compliant balloon creates a more effective hemostatic seal circumferentially about the LAA ostium. This hemostatic seal inhibits bleeding from the left atrium into the pericardial cavity. Optionally, the presence of this hemostatic seal can be confirmed (step not illustrated) with a test injection of contrast from the tip of inner sheath 101 to ensure that the contrast injected into the LAA does not flow back into the left atrium.

Optionally, another embodiment of this method may include a set of electromagnetic coils 113 located within inflatable balloon 102, and a set of electromagnetic coils 114 located within inflatable balloon 104. Thus, when balloons 102 and 104 are inflated, electromagnetic coils 113 and 114 also expand within the respective balloon, respectively. By way of electromagnetic forces created by these electromagnetic coils, inflated balloon 102 is pulled towards the LAA ostium by electromagnetic coils 114. Conversely, inflated balloon 104 is pulled towards the LAA ostium by electromagnetic coils 113. Thus, these electromagnetic forces promote attraction between inflated balloons 102 and 104, thereby further enhancing the hemostatic seal circumferentially about the LAA ostium. Similarly, instead of electromagnetic coils, the catheter can also include magnetic elements where one element is a magnet and the other element is a magnet or has a metallic component that is attracted to a magnet.

At step 304, inflated balloon 102 is pulled in a direction from within the LAA interior and towards to the LAA ostium to occlude the LAA ostium. Inflated balloon 102 can be pulled in a direction from within the LAA interior and towards to the LAA ostium by pulling on inner sheath 102 in the same direction.

At step 305, inflatable balloon 115 is inflated within a distal portion of the LAA interior, as shown in FIGS. 4 and 19. Inflatable balloon 115 can be inflated with the input of air, or a suitable liquid material, such as saline, via inflation port 112 through inner sheath openings 116 a, 116 b, and 116 c. Optionally, the suitable liquid material can be mixed with radiopaque contrast to provide spatial guidance. Inflatable balloon 115 is more compliant and thus, when inflated, it assumes the contours of its surroundings, as shown in FIGS. 4 and 19. By assuming the contours of its surroundings in the LAA, inflated balloon 115 seals the potential sites for tear or perforation in the LAA wall, thereby inhibiting bleeding (a) from the left atrium into the pericardial cavity, and (b) from the LAA into the pericardial cavity. Additionally, due to the presence of deep crypts or recesses in-between the pectinate muscles and the presence of protrusions or lobes in the LAA interior, as shown in FIGS. 16, 18-19, an inflated balloon 115 also covers these crypts, recesses, protrusions, and lobes. Furthermore, inflated balloon 115 pushes inflated balloon 102 towards the LAA ostium.

Optionally, inflatable balloons 102 and 115 can each have biocompatible hydrogel coated to its exterior (step not illustrated in FIG. 3). Biocompatible hydrogel expands upon contact with fluid, such as blood or water. By absorbing the surrounding fluid, such as blood, the hydrogel helps to inhibit bleeding from the left atrium to the pericardial cavity, or from the LAA into the pericardial cavity. Alternatively, inflatable balloons 102 and 115 can each have sponges attached to its exterior (step not illustrated in FIG. 3). The sponges will expand upon contact with fluid, such as blood or water. Like the hydrogel, the purpose of the sponges is to absorb surrounding fluid, such as blood, thereby inhibiting bleeding from the left atrium to the pericardial cavity, or from the LAA into the pericardial cavity.

At step 306, outer sheath 103 is advanced to position a distal end of outer sheath 103 in a portion of the left atrium adjacent to the LAA ostium, as shown in FIGS. 4 and 19.

At step 307, inflatable balloon 104 is inflated within a portion of the left atrium adjacent to the LAA ostium, as shown in FIGS. 4 and 19. Inflatable balloon 104 can be inflated with the input of air, or a suitable liquid material, such as saline, via inflation port 112 through outer sheath openings 106 a, 106 b, and 106 c. Optionally, the suitable liquid material can also be mixed with radiopaque contrast. Unlike the LAA interior, the left atrium portion adjacent to the LAA ostium is smooth-walled. When inflated, balloon 104 has a larger diameter than that of the LAA ostium, as shown in FIG. 4. By having a larger diameter than that of the LAA ostium, inflated balloon 104 envelops the LAA ostium to firmly occlude the LAA ostium to create an effective hemostatic seal, thereby inhibiting bleeding from the left atrium into the pericardial cavity. Additionally, inflated balloon 104 prevents inflated balloon 102 from falling into the left atrium and thus, inflated balloon 104 helps render stationary inflated balloon 102 within the LAA interior.

At step 308, inflated balloon 104 is pushed in a direction from within the left atrium portion adjacent to the LAA ostium and towards the LAA ostium. Inflated balloon 104 can be pushed in a direction from within the left atrium portion adjacent to the LAA ostium and towards the LAA ostium by pushing the outer sheath in the same direction. As a result, inflated balloon 104 occludes the LAA ostium more firmly to create an effective hemostatic seal, thereby inhibiting bleeding from the left atrium into the pericardial cavity. Additionally, inflated balloon 104 prevents inflated balloon 102 from falling into the left atrium and thus, inflated balloon 104 helps render stationary inflated balloon 102 within the LAA interior.

Optionally, inflated balloon 104 has caliber tubes attached to its exterior (step not shown in FIG. 3). These tubes will allow for the application of vacuum or suction forces to the left atrial tissue or to the surfaces of the adjacent balloon to provide for a tighter hemostatic seal.

At step 309, locking means 109 is activated. Locking means 109 is a spring-loaded device housed in inner sheath 101 that, upon activation, the protrusions would bulge out through the corresponding protrusion slots on outer sheath 103. These protrusions and corresponding protrusion slots can be of varying dimensions. The purpose of locking means 109 is to render stationary inflated balloons 102 and 104 so that the hemostatic seal is firmly occluding the LAA ostium.

Optionally, another embodiment of this method may include an additionally step of inflating an additional inflatable balloon located on the outer sheath, as shown in FIG. 20. This additional inflatable balloon is inflated in a portion of the left atrium adjacent to the fossa ovalis or the interatrial septum, as shown in FIG. 20. This balloon serves as an anchor to render stationary inflated balloon 104. Optionally, an additional locking mechanism similar to locking means 109 can be present on outer sheath 103 (not illustrated in FIG. 1). This additional locking mechanism would be used to render stationary (a) an additional anchoring balloon inflated within the left atrium adjacent to the interatrial septum, and (b) outer sheath 103. Like locking mechanism 109, this additional locking mechanism would be a spring-loaded device housed in inner sheath 101 that, upon activation, the protrusions would bulge out through the corresponding protrusion slots on outer sheath 103, as shown in FIG. 2. These protrusions and corresponding protrusion slots can be of varying dimensions.

At step 310, inner catheter 117 is advanced to position a distal end of inner catheter 117 within a distal portion of the LAA interior near an apex of the LAA. As shown in FIG. 1, the distal end of inner catheter 117 comprises tissue-penetrating tip 118.

At step 311, tissue-penetrating tip 118 of inner catheter 117 punctures a wall of the LAA apex from within the LAA interior and into the pericardial cavity, as shown in FIG. 6. Tissue-penetrating tip 118 can be a blunt or sharpened tip, and can further comprise a RF electrode delivering RF current sufficient to puncture the LAA wall tissue and the parietal pericardium. Upon puncturing the wall of the LAA apex, no significant blood will enter the pericardial cavity because of the tight hemostatic seal previously formed by the inflated balloons. After tissue-penetrating tip 118 punctures the LAA wall, the distal end of inner catheter 117 is advanced into the pericardial cavity, as shown in FIG. 6.

At step 312, the distal end of inner catheter 117 advances through the pericardial cavity, along the anterior surface of the ventricle, to a region adjacent to the sternum, and in particular, the xiphisternum, as shown in FIGS. 7-8A. The xiphisternum, also known as the xiphoid process, is the lowermost part of the sternum. Alternatively, inner catheter 117 can be advanced through the pericardial cavity to another site at which inner catheter 117 will be exteriorized. Other desired sites of exteriorization include the parietal pericardium in the right or left pectoral regions, as such as FIG. 8B. This will allow for insertion of the snare to ligate the LAA with an incision made in the skin over the intercostal space in the right or left pectoral regions (the desired site of exteriorization). Furthermore, other desired sites of exteriorization may include any other region higher up in the chest, lateral to the sternum between the ribs.

At step 313, when inner catheter 117 reaches the desired site of exteriorization, tissue-penetrating tip 118 punctures the wall of the pericardial cavity at this site. This wall of the pericardial cavity is also known as the parietal pericardium. The pericardial cavity is punctured from within the pericardial cavity in an outward direction at the desired site of exteriorization, and inner catheter 117 enters the subcutaneous tissues at the desired site of exteriorization. As shown in FIGS. 7-8A, a desired site of exteriorization is the region adjacent to the xiphisternum. Alternatively, as shown in FIG. 8B, other desired sites of exteriorization include the parietal pericardium in the right or left pectoral regions.

At step 314, inner catheter 117 is externalized or “pulled out” from the pericardial cavity with manual force, electromagnetic force, radio frequency energy delivery, or any combination thereof. For example, as shown in FIG. 8A, inner catheter 117 can be externalized from the pericardial cavity with electromagnetic forces applied with another catheter having an electromagnetic probe that is placed at the desired site of exteriorization. A small incision can be made in the skin to the left of the xiphisternum, or higher up in the chest for example, lateral to the sternum between the ribs. An electromagnetic probe is introduced towards the pericardial cavity through this incision to attract inner catheter 117 (that has electromagnets incorporated) that is then exteriorized. The distal end of inner catheter 117 may include an electromagnetic element, which interacts with the electromagnetic probe adapted to draw inner catheter 117 out of the pericardial cavity. Application of RF current may also be considered to draw inner catheter 117 out of the pericardial cavity.

At step 315, inner catheter 117 is advanced to position a proximal end of inner catheter 117 within the distal portion of the LAA interior near the LAA apex, as shown in FIG. 14.

At step 316, inflatable balloon 119 is inflated within the distal portion of the LAA interior near the LAA apex, as shown in FIG. 14. Inflatable balloon 119 can be inflated with the input of air, or a suitable liquid material, such as saline, via inflation port 112 through inner catheter opening 120. Optionally, the suitable liquid material can be mixed with radiopaque contrast to provide spatial guidance. Inflatable balloon 119 serves to anchor the LAA and hence, inflated balloon 119 can be termed the anchoring balloon.

At step 317, inflated balloon 119 is pulled in a direction from within the distal portion of the LAA interior near the LAA apex and towards the pericardial cavity to anchor the LAA. Inflated balloon 119 can be pulled in a direction from within the distal portion of the LAA interior near the LAA apex and towards the pericardial cavity by pulling inner catheter 117 in the same direction. This will serve to straighten the LAA (a structure than can be very tortuous in its course) and thus make it easier to (a) advance closure device 1300 over the exterior of the LAA, and (b) deflate the inflated balloons (step not illustrated).

At step 318, the exteriorized inner catheter 117 is used as a rail over in which closure device 1300 is advanced to the LAA, and is advanced over the exterior of the LAA to a position overlying the LAA ostium so that closure will seal the interior of the LAA and isolate any clot from the left atrium, as shown in FIG. 9. Closure device 1300 is made up of suture 1301 looped through two semi-rigid hollow tubes 1302 and 1303 which can function as a “lasso” or a “snare,” as shown in FIGS. 9 and 11-13.

At step 319, closure device 1300 is deployed over the exterior of the LAA ostium, as shown in FIGS. 9 and 11-13. Closure device 1300 is deployed over the exterior of the LAA ostium by position each of the semi-rigid hollow tubes along the short axis (or short diameter) of the exterior of the LAA ostium, and thereafter tightening the suture to seal the interior of the LAA ostium. As shown in FIG. 11, closure device 1300 applies forces along the short axis or short diameter of the oval or elliptical LAA ostium, thereby sealing the LAA ostium without a puckering effect. Optionally, as shown in FIG. 13, semi-rigid tubes 1302 and 1303 may be coated over at least an inner surface with a hydrogel, silicone gel, and/or other biocompatible material. Hydrogels will expand on contact with water or blood to further compress the LAA ostium.

At step 320, the endocardial surface of the interior of the LAA ostium is thermally or mechanically injured to induce a tissue response that enhances closure and sealing, as shown in FIG. 12. For example, thermal injury may be induced by circulating a hot fluid through inflated balloons 102 and 104 that are occluding the LAA ostium. Such injury may comprise delivering heat through inflated balloons 102 and 104 via circulation of externally heated liquids such as dextrose, glycine, saline, and glycerine, and thus creating conductive heating. Alternatively, the LAA tissue may be injured or fused by applying RF current through inflated balloons 102 and 104, and/or the external closure device. The RF current is delivered through inflated balloons 102 and 104 and/or closure device 1300, and creating resistive heating of the ostial tissues. Apposition of injured surfaces will cause “tissue welding,” i.e. cross linking of the tissue collagen, resulting in a more complete closure. Other energy sources, such as high energy focused ultrasound, mechanical abrasion, laser or cryoablation, may also be used. The combination of pressure exerted by a clip or barrette and adhesions formed at the endocardial surface will exert a synergistic effect in ensuring that the occlusion at the LAA ostium is complete and persistent.

Optionally, after step 20 (steps not illustrated in FIG. 3), an alternative embodiment can further include the steps of: deflating the first inflated balloon, deflating the second inflated balloon, deflating the third inflated balloon, deactivating the locking mechanism, removing the outer sheath from the body cavity, and removing the inner sheath from the body cavity.

FIG. 4 is a first perspective view depicting the initial steps of the exemplary embodiment of FIG. 3.

FIG. 5 is a second perspective view depicting the initial steps of the exemplary embodiment of FIG. 3.

FIG. 6 is a third perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 6 illustrates the advancement of the inner catheter through the wall of the LAA and into the pericardial cavity surrounding the heart.

FIG. 7 is a fourth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 7 illustrates the further advancement of the inner catheter through the pericardial cavity and into a region adjacent to the xiphisternum.

FIG. 8A is a fifth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 8A illustrates the inner catheter being “pulled out” and exteriorized by way of electromagnetic forces.

FIG. 8B illustrates alternative sites for exteriorizing the inner catheter after it has been drawn from the pericardial site.

FIG. 9 is a sixth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 9 shows the deployment of the closure device being advanced over the exteriorized inner catheter and to the LAA ostium.

FIG. 10 illustrates a prior art closure device employing a loop or suture which results in puckering of the LAA ostium. With a ligating circumferentially applied suture, such as in a “purse string” manner, the fixed circumference of the LAA is now compressed by the suture into a smaller area. Hence, a puckering of the LAA ostium results. With puckering, communications are likely to occur between the left atrium and the LAA. The ostium of the LAA is likely to be incompletely occluded. This is especially true of the ostium of the LAA which is more an oval rather than a circular structure. The circumference or perimeter that remains fixed is being compressed into a smaller area by the constricting suture or tie. Furthermore, a circumferentially tied-suture is also more likely to cause a tear in the LAA wall. Therefore, puckering compromises the occlusion of the LAA and potentially allows the release of clot back into the left atrium.

FIG. 11 is a seventh perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 9 illustrates the deployment of the closure device being deployed over the exterior of the LAA ostium without creating a puckering of the LAA ostium. With the application of a flat clip or similar closure, the circumference of the base of the LAA is not compressed into a smaller area and puckering does not result. Closure device 1300 is an example of a clip-like device. During deployment of closure device 1300, forces are applied along the short axis/diameter of the oval LAA ostium. Closure device 1300 applies forces along the short axis or short diameter of the oval or elliptical LAA ostium. Hence, a barrette or clip-like device such as closure device 1300 applied at the ostium of the LAA is more likely to seal off the structure. Force applied along the long diameter is less likely to approximate the opposite surfaces since (a) the two surfaces will have to travel a longer distance and (b) a greater amount of force will be necessary to overcome the elasticity/recoil of the tissue. Such a clip, such as closure device 1300, is also less likely to tear or lacerate the LAA than a suture.

FIG. 12 is an eighth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 12 illustrates the injury of the inner surface of the LAA prior to closure, where the injury causes an injury response which results in a more complete sealing along the opposed tissue surfaces.

As shown in FIG. 12, the inner wall of the LAA ostium will preferably be injured to induce to induce a tissue response that enhances closure and sealing. For example, thermal injury may be induced by circulating a hot fluid through inflated balloons 102 and 104 that are occluding the LAA. Alternatively, the LAA tissue may be injured or fused by applying RF current through inflated balloons 102 and 104, and/or the external closure device. Apposition of injured surfaces will cause “tissue welding,” such as cross linking of the tissue collagen, resulting in a more complete closure. Other energy sources, such as high energy focused ultrasound, mechanical abrasion, laser or cryoablation, may also be used. The combination of pressure exerted by a clip or barrette and adhesions formed at the endocardial surface will exert a synergistic effect in ensuring that the occlusion at the LAA ostium is complete and persistent.

FIG. 13 illustrates a closure device of the present disclosure, which is part of the present disclosure's system for accessing a pericardial space and preventing strokes arising from the LAA. Closure device 1300 comprises suture 1301, and hollow tubes 1302 and 1303. Hollow tubes 1302 and 1303 are preferably semi-rigid tubes that are designed to function as a clip or a barrette when closed over the base of the LAA. The use of the flat clip or barrette structure is a significant advantage over using a suture loop or equivalent closure. As shown in FIG. 10, a circumferential suture applied in a “purse string” manner), compresses the base of the LAA into a smaller area causing puckering of the ostium. Such puckering compromises the occlusion and potentially allows the release of a clot back into the left atrium. With the application of a flat clip or similar closure, the circumference of the LAA ostium is not compressed into a smaller area and puckering does not result. During application of the clip-like device, forces are applied along the short axis/diameter of the oval LAA ostium.

An exemplary clip that approximates opposed surfaces of the LAA ostium is illustrated in FIG. 11. The clip applies forces along the short axis or short diameter of the oval or elliptical LAA ostium. Hence, a barrette or clip applied at the ostium of the LAA is more likely to seal off the structure. Force applied along the long diameter is less likely to approximate the opposite surfaces since (a) the two surfaces will have to travel a longer distance and (b) a greater amount of force will be necessary to overcome the elasticity/recoil of the tissue. Such a clip is also less likely to tear or lacerate the LAA than a suture.

Optionally, hollow tubes 1302 and 1303 may be coated over at least an inner surface with a hydrogel, silicone gel, and/or other biocompatible material. Hydrogels will expand on contact with water or blood to further compress the ostium of the LAA. It is possible that the thickness of the coating may vary and may be greater over the mid-portion of the tubes. The ability of the clip-like closures of the present disclosure to slide and adjust position over the LAA contributes to the stability and tight closure which is achieved.

FIG. 14 is a ninth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3. FIG. 14 illustrates an anchoring mechanism to provide tension or traction to (a) facilitate the placement of closure device 1300 over the exterior of the LAA ostium, and (b) facilitate the deflation and removal of inflated balloons 102, 104, and 115, inner sheath 101 and outer sheath 103.

FIG. 15 is a photo depicting an exemplary anatomy of an LAA. LA is the left atrium. LSPV is the left superior pulmonary vein. L is the length of the LAA. W is the width of the LAA. O_(a) is the diameter of the LAA ostium with respect to the rough-walled portions of the LAA. For example, upon inflation, balloon 102 is approximated against O_(a). O_(e) is the diameter of the LAA ostium with respect to the smooth-walled portions of the left atrial cavity. For example, upon inflation, balloon 103 is approximated against O_(e). The upright arrow at the bottom shows an in-folding or constriction at the LAA ostium. However, this constriction is absent or less prominent at the opposite surface. In many specimens, a distinct circumferential constriction is absent at the ostium of the LAA. This raises the possibility that upon inflation of a balloon within the LAA, it may fall out of the LAA into the left atrial cavity. Inflated balloon 104 prevents inflated balloon 102 from falling into the left atrial cavity. Hence, the present disclosure provides for a plurality of inflatable balloons to create a more effective hemostatic seal.

Additionally, as shown in FIG. 15, nearly all LAA of an average adult contains pectinate muscles of greater than 1-mm in diameter. This gives the LAA a rough quality unlike the left atrial cavity, which is smooth-walled. Additionally, as shown in FIG. 15, deep recesses are presents within the LAA in-between the pectinate muscles. The presence of these recesses in-between the pectinate muscles make it difficult for a singular inflated balloon to effectively seal the LAA. Hence, the present disclosure provides for a plurality of inflatable balloons to create a more effective hemostatic seal.

FIG. 16 is an exemplary depiction of an LAA showing the presence of distinct protrusions termed lobes within the LAA. 1601 is the circumference of the LAA ostium. 1602, 1603, and 1604 are protrusions termed lobes and are located within the LAA. The presence of lobes 1602, 1603, and 1604 and the recesses in-between the pectinate muscles make it difficult for a singular inflated balloon to effectively seal the LAA. Hence, the present disclosure provides for a plurality of inflatable balloons to create a more effective hemostatic seal.

FIG. 17 is an exemplary depiction of an LAA in accordance with the hour-glass concept. One of the key factors affecting the time measured in the hour-glass is the neck width. The present disclosure is based on the concept that preventing the sand or water flowing from the top bulb to the bottom is achieved by occluding or sandwiching the neck by a combination of balloons rather by inflating one balloon in the bottom bulb only. The balloons (inflatable balloons 102 and 104) that are placed immediately across the neck are approximated towards each other by a combination of pushing and pulling. For example, inflatable balloon 102 is pushed upwards by inflatable balloon 115 and is pulled by manual traction on inner sheath 101 as well as by electromagnetic coils 114 applied from inflatable balloon 104. Inflatable balloon 104 is pushed towards the neck and towards inflatable balloon 102 by manual forces applied on outer sheath 103 and are also pulled by electromagnetic forces 113 (or suction forces) applied from inflatable balloon 102. The top bulb represents the left atrial cavity while the bottom bulb represents the LAA. The neck represents the LAA ostium.

FIG. 18 is another exemplary depiction of an LAA in accordance with the hour-glass concept. The detailed description of FIG. 17 is equally applicable to FIG. 18. The top bulb represents the smooth-walled left atrial cavity while the bottom bulb of the hour glass represents the rough-walled LAA with the pectinate muscles and lobes. Upon inflation, inflatable balloons 102 and 115 are less likely to provide an effective hemostatic seal without inflatable balloon 104. Inflatable balloon 104 is approximated against the smooth-walled left atrial cavity. Inflatable balloon 104 serves as the key expanding element because (a) it prevents inflatable balloon 102 from falling into the left atrium, and (b) firmly occludes the LAA ostium to enhance the hemostatic seal. By way of electromagnetic coils 113, inflatable balloon 104 is pulled towards the neck of the hour-glass, which is the LAA ostium. Inflatable balloon 115 pushes inflatable balloon 102 towards the LAA ostium.

FIG. 19 is a tenth perspective view depicting the intermediate steps of the exemplary embodiment of FIG. 3, and in particular, FIG. 19 illustrates the accentuation of the waist of the LAA ostium and the wall of the proximal portion of the LAA caused by the inflation of the non-compliant balloon. For brevity, the detailed descriptions of steps 302 to 308 of FIG. 3 are incorporated by reference herein. Inflatable balloon 102 is inflated within the LAA interior adjacent to the LAA ostium. Inflatable balloon 102 is non-compliant and is inflated with higher pressure. As a non-compliant balloon, inflatable balloon 102 deforms and expands the walls of the LAA and in particular, the waist of the LAA. As shown in FIG. 19, the dotted line shows the expansion of these LAA walls and LAA waist by inflated balloon 102. The dotted line shows the expansion of these LAA walls and LAA waist. The LAA is more distensible than the left atrium and hence, should readily deform in response to a high pressure inflation of non-compliant balloon 102. After inflation, non-compliant balloon 102 is pulled towards the LAA ostium. Inflatable balloon 115 is inflated within the distal portion of the LAA interior and is largely compliant. Upon inflation, balloon 115 conforms to its surroundings in the LAA and pushes inflated balloon 102 towards the LAA ostium, as shown in FIG. 19. Additionally, inflated balloon 115 prevents inflated balloon 102 from being pushed away from the LAA ostium. Inflatable balloon 104 is inflated within the left atrium portion adjacent to the LAA ostium, as shown in FIG. 19. After inflation, balloon 104 is pushed towards the LAA ostium, and will prevent inflated balloon 102 from falling into the left atrium. Finally, inflated balloons 102 and 104 are manually pushed towards each other by pulling on the inner sheath and pushing on the outer sheath, respectively.

Alternatively, it is contemplated that one inflatable balloon can have multiple internal compartments within the balloon such that each internal compartment effectively operates as a separate inflatable balloon. For example, it is contemplated that one inflatable balloon can have three internal compartments such that each of these three internal compartments effectively operate in a similar manner as inflatable balloons 102, 104, and 115 shown in FIG. 19, respectively. Thus, upon inflation, this one inflatable balloon covers the area from (a) the region of the left atrium adjacent to the LAA ostium, to (b) the distal portions of the LAA interior, as currently achieved by the combination of inflatable balloons 102, 104, and 115 shown in FIG. 19.

FIG. 20 is a perspective view depicting an optional step of the exemplary embodiment of FIG. 3. Optionally, another embodiment of this method may include an additionally step between steps 309 and 310 of inflating an additional inflatable balloon 123 located on outer sheath 103, as shown in FIG. 20. Inflatable balloon 123 is attached to the distal end of outer sheath 103, and is inflated within a portion of the left atrium adjacent to the interatrial septum, as shown in FIG. 20. Alternatively, inflatable balloon 123 can be inflated adjacent to the fossa ovalis. This balloon serves as an anchor to render stationary inflated balloon 104 and prevent outer sheath 103 from getting pulled back.

FIG. 21 illustrates an aspect of the present disclosure in which a tissue-penetrating tip 2102 may enter the LAA through a wall of the LAA, as disclosed in U.S. patent application Ser. No. 13/922,070, entitled “APPARATUS AND METHOD FOR TREATING BLEEDING ARISING FROM LEFT ATRIAL APPENDAGE,” filed Jun. 19, 2013. The entire contents of U.S. patent application Ser. No. 14/941,457 are incorporated herein by reference, including the portion of U.S. patent application Ser. No. 14/941,457 directed to entering the wall of the LAA through a wall of the LAA. In this situation, the LAA is being entered from the exterior/pericardial space that has been accessed surgically.

The tissue-penetrating tip 2102 may enter the LAA at or near the apex or tip of the LAA.

FIG. 22 illustrates an aspect of the present disclosure in which the tissue-penetrating tip 2102 has proceeded into the Left Atrium Cavity. The tissue-penetrating tip 2102 may be the tip of a body 2202 that extends through the LAA. Inflatable balloons 2204, 2206 may be coupled to sheaths 2208 (of different diameters that can slide over each other and thus the balloons can be moved with respect to each other) that extends over the body 2202. The balloons 2204, 2206 may be inflated in any manner disclosed in U.S. patent application Ser. No. 14/941,457 or the present application to produce a seal of the LAA ostium. In one embodiment, electromagnetic coils 2210, 2212 may be used to attract the balloons 2204, 2206 towards each other in any manner disclosed in U.S. patent application Ser. No. 14/941,457 or the present application. FIG. 23 illustrates the balloons 2204, 2206 attracted towards each other to produce a seal of the LAA ostium using magnetic, electromagnetic or suction forces.

FIG. 24 is a representation of a possible complication with inserting a tissue-penetrating tip 2402 through a wall 2404 of a LAA 2406. It is possible that the wall 2404 may invaginate upon puncture by the tip 2402, as represented by the dashed lines in FIG. 24. This may be undesirable, as the tip 2402 may puncture the wall 2404 abruptly, resulting in a tear of the LAA and bleeding. The wall 2404 of the LAA 2406 is thin, compliant, and collapsible, which may increase the possibility of invagination.

FIG. 25 illustrates an embodiment of the present disclosure, in which a suction device is utilized. The suction device may comprise a device for applying a suction force to a surface 2504 of the LAA 2406. The surface 2504 may comprise an outer surface of a wall of the LAA 2406. In one embodiment, the suction device may comprise a tube 2502, as shown in FIG. 25, including a lumen 2506 for transmitting the suction force through low pressure, or vacuum, or the like. In other embodiments, another form of suction device may be utilized. An end 2508 of the tube 2502 may be configured to be placed against the outer surface of the LAA 2406 to apply the suction force.

The suction force applied by the suction device may serve to stabilize the LAA 2406 while the LAA 2406 is being punctured by the tip 2402. The suction force may hold the wall of the LAA 2406, and may also draw the wall of the LAA 2506 towards the end 2508 of the suction device, to reduce the possibility of invagination. The suction force may hold the wall of the LAA 2406 while the tip 2402 punctures the wall from exterior of the LAA 2506 to interior of the LAA 2506. The tip 2402 may comprise a tip of a body 2510 that extends within the tube 2502. The body 2510 may pass through the lumen 2506 of the tube 2502. The body 2510 may extend coaxial with the suction device.

FIG. 26 illustrates an embodiment of the present disclosure in which the suction device includes a sheath 2602 that extends over the tube 2502. The suction device may comprise the sheath 2602, which provides a suction force, and may also incorporate suction provided by the tube 2502. The sheath 2602 may extend over the outer surface of the tube 2502. The sheath 2602 may have a greater diameter than the tube 2502, and accordingly the tube 2502 may extend within the lumen of the sheath 2602 and will be advanced forwards towards the LAA as the tip is pulled back by suction forces applied by the tube. The sheath 2602 may include an end 2510 that is configured to be placed against the outer surface of the LAA 2406 to apply the suction force. The additional diameter of the sheath 2602 by enveloping the puncture may provide for additional control of the LAA during puncture by the tip 2402.

FIGS. 27A-C illustrate an embodiment of a suction device 2702 including a plurality of tubes 2704 a-c. FIG. 27A illustrates a side perspective view of the suction device 2702 applying a suction force to a surface 2504 of the LAA. The plurality of tubes 2704 a-c may be coupled to a central tube 2706. The central tube 2706 may include a lumen 2708 for the tissue penetrating tip 2102 to pass therethrough, in a similar manner as with the tube 2502.

The plurality of tubes 2704 a-c may be spaced apart from each other on the central tube 2706. In one embodiment, the plurality of tubes 2704 a-c may be positioned on an outer surface of the tube 2706. In one embodiment, the plurality of tubes 2704 a-c may have a varied position or orientation than show in FIGS. 27A-C. In one embodiment, a varied number of tubes 2704 a-c than shown in FIGS. 27A-C may be utilized.

The plurality of tubes 2704 a-c may each be configured to apply a suction force to the surface of a LAA. The multiple tubes 2704 a-c utilized may disperse the position of the suction force, to reduce the possibility of a single suction force being applied to the surface of the LAA at a single location. The multiple tubes 2704 a-c may also have a diameter that is smaller than the central tube 2706. The smaller size of the multiple tubes 2704 a-c may also reduce the possibility of a portion of the wall of the LAA being sucked into one of the tubes 2704 a-c or the lumen of the central tube 2706. If a portion of the wall of the LAA is sucked into any of the tubes disclosed herein, then an uneven or undesired puncture of the LAA wall may occur, as the LAA wall may enter the tube unevenly. Different points of suction may be provided. The multiple tubes 2704 a-c may provide a taut and substantially even surface of the LAA wall for puncture, as represented in FIG. 27A. A narrow puncture site is preferably provided. The tissue-penetrating tip 2102 may be able to penetrate the surface of the LAA wall at a substantially perpendicular angle. In one embodiment, a plurality of regions may be coupled to the central tube 2706, each providing a suction force.

FIG. 27B illustrates the suction device 2702 without the LAA wall being shown.

FIG. 27C illustrates a front view of the end of the suction device 2702, displaying the lumen 2708 for receiving the tissue-penetrating tip 2102 and accompanying body of the penetrating device. The multiple tubes 2704 a-c are displayed at spaced apart positions on the central tube 2706. The multiple tubes 2704 a-c may be positioned outside and adjacent to the central tube 2706 where the tip 2102 will be inserted.

The embodiments shown in FIGS. 25-27 may provide for additional control of the LAA during puncture of the LAA, and reduction of undesired puncturing and bleeding of the LAA.

A method corresponding to one or more of the embodiments of FIGS. 25-27 and/or one or more embodiments disclosed herein or incorporated by reference herein may include applying a suction force to a surface of a LAA with a suction device, and puncturing the surface of the LAA using a tissue-penetrating tip while the suction force is applied to the surface. The suction device may comprise a plurality of tubes. The plurality of tubes may be coupled to a central tube. The tissue-penetrating tip may comprise a tip of a body extending within the central tube. The central tube may not apply a suction force to the surface of the LAA while the surface of the LAA is punctured using the tissue-penetrating tip. The plurality of tubes may be spaced apart from each other on the central tube. The central tube may include a lumen for the tissue-penetrating tip to extend through. The surface of the LAA may be a wall of the LAA, and a step of puncturing may comprise puncturing the wall of the LAA with the tissue-penetrating tip from exterior of the LAA to interior of the LAA. The method may incorporate other method steps or systems disclosed herein or incorporated by reference herein.

The systems and methods disclosed in regard to FIGS. 25-27 may be incorporated into any system or method disclosed in this application or in U.S. patent application Ser. No. 14/941,457.

FIG. 28 illustrates an embodiment of the present disclosure in which an inflatable balloon 2802 is inflated within a cavity of the LAA 2406. The inflatable balloon 2802 may be coupled to a sheath 2804 that is passed through a wall of the LAA, in any manner disclosed in this application or in U.S. patent application Ser. No. 14/941,457. The LAA may be entered from the exterior/pericardial space that has been accessed surgically.

The inflatable balloon 2802, upon inflation, may apply pressure against an interior surface of the LAA. The pressure applied by the inflatable balloon 2802 may be applied in a direction towards the exterior of the LAA. The pressure applied by the inflatable balloon 2802 may be provided by the pressure of inflation, or may be provided by a force caused by the sheath 2804 being drawn in a direction towards the exterior of the LAA. The inflatable balloon 2802 may be inflated and pulled back towards the entry site.

A pressure applicator device 2808 may be used to apply pressure to the LAA in a direction opposite to the pressure applied by the inflatable balloon 2802. The pressure applicator device 2808 may be pushed towards the LAA wall. The pressure applicator device 2808 may comprise a sleeve or other form of pressure applicator device that is configured to apply pressure to the outer surface of the LAA. In the embodiment shown in FIG. 28, the pressure applicator device 2808 may have a funnel shape configured to contour to the shape of the LAA. The funnel shape may increase the area over which pressure is applied. In one embodiment, the pressure applicator device 2808, and/or the inflatable balloon 2802 may have shapes that complement each other. For example, in one embodiment, the inflatable balloon 2802 may have a conical shape and the pressure applicator device 2808 may have a funnel shape.

The pressure applicator device 2808 may be coupled to the sheath 2804. A locking mechanism 2810, such as a spring locking mechanism disclosed in this application may be used to maintain the forces provided by both the inflatable balloon 2802 and the pressure applicator device 2808. The locking mechanism 2810 may be used to hold and lock the inflatable balloon 2802 and the pressure applicator device 2808 in position relative to each other.

The pressures applied by the inflatable balloon 2802 and the pressure applicator device 2808 may comprise counter-pressures. The pressures may be applied in opposite directions. The counter-pressures may substantially counter balance each other. The counter-pressures may serve to provide a compressive force against a wall of the LAA in both an endocardial and an epicardial direction. The compressive force may serve to seal the LAA ostium or the LAA puncture site, and/or prevent bleeding from the wall of the LAA.

With epicardial surgical cannulation of the LAA and a subsequent inflation of a balloon within the LAA, it may not be necessary to provide a system of multiple balloons or expanding elements adhering to each other with a balloon inflated within the left atrial cavity to achieve a tight seal across the LAA ostium. The operator may have ready access to the pericardial cavity and epicardial surface of the LAA, and, after inflating a balloon in the LAA cavity, pressure can be applied with a constricting device or loop from the epicardial surface. The pressure provided by the inflatable balloon 2802 and the pressure applicator device 2808 may comprise counter-pressures, that serve to counterbalance the pressure from the other device. The term counter-pressure refers to a pressure applied in one direction to counterbalance pressure from another. As such, as shown in FIG. 28, a pressure may be applied to both sides of the LAA, in a circumferential manner, near the puncture site. The wall of the LAA is compressed from both the endocardial and epicardial directions. Hemostasis may be desirably maintained within the LAA.

FIG. 29 illustrates an embodiment of a pressure being applied by an inflatable balloon 2902 in a similar manner as disclosed in regard to the embodiment of FIG. 28. The LAA may be entered from the exterior/pericardial space that has been accessed surgically. The inflatable balloon 2902, however, has a first portion 2904 and a second portion 2906. The first portion 2904 may have a different degree of compliance than the second portion 2906. The first portion 2904, for example, may be less compliant than the second portion 2906. The first portion 2904, as shown in FIG. 29 may also have a wider diameter than the second portion 2906.

The pressure applicator device 2908 may have a funnel shape to complement the conical shape of the second portion 2906. The inflatable balloon 2902 and pressure applicator device 2908 may each provide a counter-pressure that counter balances each other in a similar manner as disclosed in regard to the embodiment of FIG. 28. The pressure applicator device 2908 may be pressed against the outer surface of the LAA wall, and the inflatable balloon may be inflated to provide a pressure against the inner surface of the LAA wall, or may be drawn towards the inner surface of the LAA wall. An effective counter pressure may be provided in the embodiment of FIG. 29 that is achieved over a larger area than shown in regard to the embodiment of FIG. 28.

FIG. 30 illustrates an embodiment of the present disclosure in which an inflatable balloon 3002 is inflated within a cavity of the LAA 2406. The LAA may be entered from the exterior/pericardial space that has been accessed surgically. The inflatable balloon 3002 may be coupled to a sheath 3004 that is inserted into the cavity of the LAA 2406. The sheath 3004 may pass through a wall of the LAA 2406. The inflatable balloon 3002 may include an indentation 3006. The indentation 3006 may have the form of a groove that extends circumferentially around the balloon 3002. The indentation 3006 may be pre-formed into the inflatable balloon 3002.

In the embodiment shown in FIG. 30, a constricting tie 3008 may be applied around the exterior surface of the LAA 2406. The constricting tie 3008 may take the form of a band or other device configured to constrict the LAA 2406. The constricting tie 3008 may be positioned over the exterior surface of the LAA 2406 and may engage the indentation 3006 of the balloon 3002 through the wall of the LAA 2406. The indentation 3006 of the balloon 3002 may serve to prevent the tie 3008 from slipping upon being placed on the LAA 2406. The tie 3008 may serve to maintain hemostasis for the LAA 2406. Although not shown in this Figure, an embodiment includes suction tubes attached to the surface of the balloon 3002. Upon application of suction, the LAA wall will adhere effectively to the inflated balloon and thus prevent bleeding from the puncture site.

The embodiments shown in FIGS. 28-30 may provide for hemostasis of the LAA 2406 after puncturing the structure. The embodiments shown in FIGS. 28-30 may provide for a hemostasis of the LAA 2406 without use of multiple balloons within the LAA and/or within the left atrium.

A method corresponding to one or more of the embodiments of FIGS. 28-30 and/or one or more embodiments disclosed herein or incorporated by reference herein may include inflating an inflatable balloon within the cavity of the left atrial appendage (LAA), and applying pressure to an interior surface of the LAA, with the inflatable balloon, in a direction towards exterior of the LAA. The method may include applying pressure to an exterior surface of the LAA, with a pressure applicator device, in a direction towards the cavity of the LAA while the pressure to the interior surface of the LAA is being applied with the inflatable balloon to the interior surface in the direction towards exterior of the LAA. The pressure applicator device may be a sleeve extending over the exterior surface of the LAA. At least a portion of the pressure applicator device may have a shape that complements a shape of at least a portion of the inflatable balloon. The pressure that is applied to the interior surface of the LAA and the pressure applied to the exterior surface of the LAA may compress a wall of the LAA in both the endocardial and the epicardial directions. The inflatable balloon may have a first portion that is more compliant than a second portion of the inflatable balloon. The pressure that is applied to the interior surface of the LAA may substantially counter balance the pressure applied to the exterior surface of the LAA. The inflatable balloon may have an indentation. The method may further comprise applying a constricting tie to an exterior surface of the LAA to engage the indentation of the inflatable balloon through a wall of the LAA. The method may also include application of suction from the surface of the inflatable element that is deployed within the LAA. The method may incorporate other method steps or systems disclosed herein or incorporated by reference herein.

The systems and methods disclosed in regard to FIGS. 28-30 may be incorporated into any system or method disclosed in this application or in U.S. patent application Ser. No. 14/941,457.

FIG. 31 illustrates an embodiment of the present disclosure in which suction devices are utilized with one or more of the inflatable balloons 102, 104, 115. The suction devices may take the form of tubes 3102 that are coupled to one or more of the inflatable balloons 102, 104, 115. The suction devices may be configured to provide a suction force. The suction force may be used to attract any of the balloons 102, 104, 115 to each other, or may be used to attract any of the balloons 102, 104, 115 to an interior surface of the LAA. The suction force may be used to attract adjacent the balloons 102, 104, 115 to each other. In one embodiment, the suction devices may be used to attract the balloons 102, 104 to each other to seal the LAA ostium. In one embodiment, the suction devices may be used as a substitute for the electromagnetic coils disclosed in this application.

The suction devices may be coupled to any of the inflatable balloons 102, 104, 115 as desired. In one embodiment, the suction devices may be positioned on the outer surface of any of the inflatable balloons 102, 104, 115. In one embodiment, the suction devices may be positioned on the outer surface of inflatable balloons 102, 104, 115 proximate each other, such that the suction devices are attracted to each other.

The suction devices disclosed in regard to FIG. 31 may be incorporated into any system or method disclosed in this application or in U.S. patent application Ser. No. 14/941,457. The suction devices may serve as a substitute for any means of attracting one feature of a system or method to another feature of the system or method, including the LAA itself.

FIGS. 32-35 illustrate a method and system for using at least one suction device to maintain a hemostatic seal at the LAA ostium. In FIG. 32, a plurality of inflatable balloons 102, 104, 115 are inflated within the cavity of the LAA. The balloon 102 may be coupled to an intermediate sheath 3202 which is positioned between the outer sheath 103 and inner sheath 101. The inner catheter 117 extends exterior to the LAA to serve as a guide path for the closure device 1300, in a manner disclosed in this application.

The suction device in the form of tubes 3102 may extend from one or multiple of the inflatable balloons 102, 104, 115 to either create attachment between the respective balloon 102, 104, 115 and the interior of the LAA, or between another balloon. Application of suction may create attachment of the balloon 104 with the wall of the LAA, close to the ostium of the LAA. The suction device may be used to seal the ostium of the LAA. In the embodiment shown in FIG. 32, tubes 3102 may be used to attach the balloon 102 to the wall of the LAA. The balloon 102 may be a relatively non-compliant balloon and may alter and distend the shape of the appendage.

The catheter 117 may perforate the LAA from within and enter the pericardial space while hemostasis is maintained. The exteriorized catheter 117 may be extended out to an exteriorized site.

In FIG. 33, the closure device 1300 is slid along the exteriorized inner catheter 117 and placed in position at the LAA ostium, as disclosed in this application. The closure device 1300 may be advanced over the exteriorized catheter from outside and deployed at the ostium of the LAA. The balloon 115 may be deflated as shown in FIG. 33. The balloon 102 may be deflated next in sequence. The balloon 104 may then be deflated next in sequence.

In FIG. 34, the exteriorized catheter 117 may be gradually pulled out from the exteriorized site from where the closure device 1300 was applied. The balloon 119 at the end of the catheter 117 may be inflated. The inflated balloon 119 may prevent the catheter 117 from completely exiting the LAA. The balloon 119 may include one or more suction devices in the form of tubes 3102 to attract the balloon 119 to the inner surface of the LAA and secure the balloon 119 in position within the LAA cavity. The tubes 3102 may be positioned on an exterior surface of the balloon 119. A lumen of the catheter 117 may provide suction force in lieu of or in combination with the suction provided by the tubes 3102.

In FIG. 34, the balloon 115 has been deflated and the inner sheath 101 has been retracted into the intermediate sheath 3202. The balloon 102 has been deflated.

The intermediate sheath 3202 may be retracted into the outer sheath 103. The balloon 104 may be deflated. The sheaths 101, 3202, 103 may be retracted until fully withdrawn from the LAA in a direction towards the left atrium cavity. FIG. 35 illustrates the sheaths 101, 3202, 103 fully retracted. The balloon 119 remains in position as the walls of the LAA extend in a direction towards the interior of the LAA. The suction device coupled to the balloon 119 continues to provide attachment between the balloon 119 and the interior surface of the LAA. The exteriorized catheter 117 will be removed from the LAA and drawn out through the exteriorized site.

A method corresponding to one or more of the embodiments of FIGS. 31-35 and/or one or more embodiments disclosed herein or incorporated by reference herein may include inflating a first inflatable balloon within a cavity of a LAA, and applying a suction force with at least one tube coupled to the first inflatable balloon to attract the first inflatable balloon to an interior surface of the LAA or to a second inflatable balloon. The second inflatable balloon may be positioned in a left atrium cavity. At least one tube may be positioned on an exterior surface of the first inflatable balloon. The first inflatable balloon may be coupled to a sheath positioned in the cavity of the LAA. The first inflatable balloon may be coupled to a catheter extending through a wall of the LAA. The method may incorporate other method steps or systems disclosed herein or incorporated by reference herein.

The method and system disclosed in regard to FIGS. 31-35 may be incorporated into any system or method disclosed in this application or in U.S. patent application Ser. No. 14/941,457.

FIG. 36 illustrates an embodiment of the present disclosure incorporating use of magnetic responsive materials 3601 with the inflatable balloons 102, 104, 115. In one embodiment, the magnetic responsive materials 3601 may take the form of a ferro fluid. The magnetic responsive materials 3601 may be coupled to one or more of the balloons 102, 104, 115. In one embodiment, the magnetic responsive materials 3601, such as a ferro fluid or magnetorheological fluid that changes viscosity in response to a magnetic field, may be positioned on an outer surface of one or more of the balloons 102, 104, 115, as shown in FIG. 36. The magnetic responsive materials 3601, such as a ferro fluid, may be inserted into a narrow tube stuck to the outer surface of the respective balloon. In one embodiment, the magnetic responsive materials 3601, such as a ferro fluid, may be utilized to inflate one or more of the balloons 102, 104, 115.

The magnetic responsive materials 3601 may be used to move any of the balloons 102, 104, 115, including attracting the balloons 102, 104, 115 to each other, or to an interior surface of the LAA, upon exposure to magnetic field. The balloons 102, 104, 115 may be caused to stick to each other or to an interior surface of the LAA. The magnetic responsive materials 3601 may be used to move one or more of the balloons 102, 104, 115 by inflating the respective balloon. The movement of the one or more balloons 102, 104, 115 may cause a seal of the LAA ostium. In one embodiment, the magnetic responsive materials 3601, such as a ferro fluid, may be used as a substitute for the electromagnetic coils disclosed in this application.

The magnetic responsive materials may be controlled by an external controller 3602. The external controller 3602 may produce a magnetic field 3604 that is used to move one or more of the balloons 102, 104, 115 in a manner disclosed in this application or an application incorporated by reference herein. The external controller 3602 may be positioned outside of the patient's body and the magnetic field may be passed through the body. The external controller 3602 may be configured to manipulate the magnetic field to control movement of the one or more of the balloons 102, 104, 115. In one embodiment, an internal controller may be utilized to move one or more of the balloons 102, 104, 115.

A method corresponding to one or more of the embodiments of FIG. 36 and/or one or more embodiments disclosed herein or incorporated by reference herein may include inserting an inflatable balloon within a cavity of a left atrial appendage (LAA) or a left atrium cavity, and applying a magnetic field to a ferro fluid coupled to the inflatable balloon while the inflatable balloon is positioned within the cavity of the LAA or the left atrium cavity, to thereby move the inflatable balloon. The method may incorporate other method steps or systems disclosed herein or incorporated by reference herein.

The magnetic responsive materials disclosed in regard to FIG. 36 may be incorporated into any system or method disclosed in this application or in U.S. patent application Ser. No. 14/941,457. The magnetic responsive materials may serve as a substitute for any means of attracting one feature of a system or method to another feature of the system or method, including the LAA itself. 

What is claimed:
 1. A method for treating and preventing bleeding arising from a left atrial appendage (LAA), comprising the steps of: inflating a first inflatable balloon coupled to a catheter, the first inflatable balloon having an exterior surface; exerting, using a first tube attached to the exterior surface of the first inflatable balloon, a suction force onto a first surface of the LAA that is adjacent to the first inflatable balloon; inflating a second inflatable balloon coupled to the catheter, the second inflatable balloon having an exterior surface; and exerting, using a second tube attached to the exterior surface of the second inflatable balloon, a suction force onto a second surface of the LAA that is adjacent to the second inflatable balloon.
 2. The method of claim 1, further comprising the step of: puncturing, using a tissue-penetrating tip, a target surface of the LAA.
 3. The method of claim 2, wherein the suction forces are being exerted while the target surface of the LAA is being punctured.
 4. The method of claim 1, wherein the first inflatable catheter balloon is located distal to an ostium of the LAA.
 5. The method of claim 4, wherein the second inflatable catheter balloon is located proximal to an ostium of the LAA.
 6. The method of claim 1, wherein the first surface and the second surface of the LAA are surfaces of an ostium of the LAA.
 7. The method of claim 1, further comprising the step of: inflating, distal to the first inflatable catheter balloon, a third inflatable catheter balloon coupled to the catheter. 